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For Peer Review Effect of adding interferential currents stimulation to exercise on outcomes in primary care patients with chronic neck pain: a randomised controlled trial Journal: Clinical Rehabilitation Manuscript ID CRE-2018-6969.R2 Manuscript Type: Original Article Date Submitted by the Author: 21-Mar-2019 Complete List of Authors: Albornoz-Cabello, Manuel; University of Sevilla, Department of Physical Therapy Pérez Mármol, José Manuel; University of Granada, Physiotherapy (Occupational Therapy) Barrios-Quintana, Cristo Jesus; Junta de Andalucia Servicio Andaluz de Salud, Physiotherapy Matarán-Peñarrocha, Guillermo Adolfo; Servicio Andaluz de Salud, Atención Primaria Castro-Sánchez, Adelaida María; University of Almería, Department of Nursing and Physical Therapy DE LA CRUZ-TORRES, BLANCA; University of Seville, Physiotherapy Keywords: Range of movement, Neck pain, Exercise, Interferential Currents http://mc.manuscriptcentral.com/clinrehab Clinical Rehabilitation
For Peer Review Abstract Objective: to evaluate the effect of adding interferential current stimulation to exercise on pain, disability, psychological status and range of motion in patients with neck pain. Design: A single blinded randomised controlled trial. Setting: Primary care physiotherapy units. Subjects: 84 patients diagnosed with non-specific mechanical neck pain. This sample was divided into two groups randomly: experimental (n=42) vs control group (n=42). Interventions: Patients in both groups had a supervised therapeutic exercise program, with the experimental group having additional interferential current stimulation treatment. Main measures: The main measures used were intensity of neck pain according to the Visual Analogue Scale; the degree of disability according to the Neck Disability Index and the CORE Outcome Measure; anxiety and depression levels according to the Goldberg scale; apprehension as measured by the Personal Psychological Apprehension scale; and the range of motion of the cervical spine. The sample was evaluated at baseline and posttreatment (10 sessions/two weeks). Results: Statistically significant differences between groups at posttreatment were observed for Visual Analogue Scale (2.73±1.24 vs 4.99±1.56), Neck Disability Index scores (10.60±4.77 vs 18.45±9.04), CORE Outcome Measure scores (19.18±9.99 vs 35.12±13.36), Goldberg total score (6.17±4.27 vs 7.90±4.87), Goldberg anxiety subscale, Personal Psychological Apprehension Scale scores (28.17±9.61 vs 26.29±11.14), and active and passive right rotation. Page 1 of 26 http://mc.manuscriptcentral.com/clinrehab Clinical Rehabilitation 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
For Peer Review Conclusions: Adding interferential current stimulation to exercise resulted in better immediate outcome across a range of measures. Page 2 of 26 http://mc.manuscriptcentral.com/clinrehab Clinical Rehabilitation 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
For Peer Review 1 1Effect of adding interferential currents stimulation to exercise on outcomes in 2primary care patients with chronic neck pain: a randomised controlled trial 3 4Introduction 5Neck pain generates a very limiting symptomatology, such as pain, a decrease in neck 6range of motion, disability or an impairment of the patient's psychological function.1 7Conclusive evidence in patients with chronic pain recommends the use of multimodal 8rehabilitation approaches, using exercises combined with other therapeutic 9interventions.2-4 Supervised therapeutic exercise has shown to be effective in the 10 treatment of neck pain and other neck disorders.3-4 Gross et al.3, in a Cochrane 11 systematic review evaluating effectiveness of exercise for neck disorders, reported that 12 strength and endurance training and stabilization and stretching exercises had a small to 13 large impact on neck pain relief in the short term. Hence, management of neck pain at 14 present is largely a matter of exercise as the only reasonably well-studied and proven 15 effective treatment. 16 Interferential current therapy uses the significant physiological effects of low17 frequency electrical nerve stimulation without the painful and somewhat unpleasant side 18 effects that are sometimes associated with low-frequency stimulation. An advantage of 19 interferential current therapy is its capacity to reduce the impedance offered by the 20 skin.5-8 Several physiological mechanism approaches, such as the ‘gate control’ theory, 21 claim that interferential current therapy may increase circulation and pain suppression 22 by blocking nerve conduction.5-9 Reviews have indicated an overall supportive evidence 23 base for interferential current therapy, especially in pain-based management.5,8,10 Page 3 of 26 http://mc.manuscriptcentral.com/clinrehab Clinical Rehabilitation 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
For Peer Review 2 24 Therefore, interferential current may increase the effectiveness of exercise in primary 25 care patients with chronic neck pain. 26 The main aim of this study was to evaluate the effect of adding interferential 27 current stimulation to exercise on pain, disability, psychological status and neck range 28 of motion in primary care patients with chronic neck pain. 29 Methods 30 The design of this trial is a prospective single blinded randomised controlled trial. The 31 trial was registered in the Australian New Zealand Clinical Trials Registry (Trial ID: 32 ACTRN12616000964415). The study period was from September 2014 to June 2017. 33 Written informed consent was obtained from each patient to be included in this study. 34 The research protocol was approved by the Andalusian Research Ethics Committee of 35 the Virgen Macarena - Virgen del Rocío University Hospital (Reference number: 079436 N-14). This clinical trial was performed in compliance with the Helsinki Declaration, 37 2013. 38 Patients diagnosed with nonspecific mechanical neck pain, from primary care 39 medical services in the health care district (La Rinconada de Sevilla, Seville, Spain) 40 were potential participants in the clinical trial. All patients that were treated at the 41 physiotherapy service were informed of the objectives and procedures of the study. 42 Patients that agreed to participate were screened by a research assistant (within 1-3 43 working days after admission) to assess their eligibility. A total of 84 patients met the 44 selection criteria and agreed to participate. Patients were recruited prior to day five of 45 admission. The participants in the clinical trial received the study interventions at the 46 physiotherapy service. Page 4 of 26 http://mc.manuscriptcentral.com/clinrehab Clinical Rehabilitation 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
For Peer Review 3 47 Participants were included in this study if they met the following criteria: (1) 48 non-specific mechanical neck pain (chronic neck pain diagnosed by a physician)11; (2) 49 age between 18 and 65 years old; (3) both men and women were accepted; (4) lack of 50 apprehension toward electrotherapy. The exclusion criteria were: (1) metal implants in 51 the spine; (2) apprehension to electrotherapy (a score of >45 points on the Personal 52 Psychological Apprehension scale);10 (3) cervicogenic headache; (4) cervicogenic 53 dizziness; (5) neck pain associated with neurological deficits; (6) unexplained fever; (7) 54 cervical surgery associated with persistent pain; (8) specific diagnoses such as cervical 55 myelopathy, cervical stenosis, osteomyopathy, and visceral pain referred to the neck or 56 non-cervical cause. 57 Following the initial baseline evaluation, patients were randomly assigned to 58 either the supervised exercise group or the interferential current therapy plus supervised 59 exercise group. Randomisation was executed by a computerised random number 60 generator before starting data collection by a researcher not involved in the recruitment 61 or the treatment phases. Individual and sequentially numbered index cards with the 62 random assignment were prepared. The cards were put inside sealed opaque envelopes. 63 A research assessor, blinded during the baseline examination, opened the envelopes and 64 allocated each patient to their corresponding treatment group.12 65 The interventions were provided by a physiotherapist with more than 11 years of 66 experience in the physiotherapy service of San José de La Rinconada health centre (La 67 Rinconada de Sevilla, Seville, Spain). Participants received 10 sessions from Monday to 68 Friday for two weeks. The duration of each session was approximately one hour and a 69 half. The physiotherapist recorded attendance at sessions. 70 The control group only received a supervised therapeutic exercise programme, in 71 which the exercises were provided in group sessions and one on one. The control group Page 5 of 26 http://mc.manuscriptcentral.com/clinrehab Clinical Rehabilitation 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
For Peer Review 4 72 had no extra treatment during the study. The main objective of the supervised exercises 73 was to induce relaxation and pain relief while improving the neck muscles' flexibility 74 and strength. The supervised exercises included: 1) ergonomic advice on reducing 75 repetitive motions and/or maintained positions; and 2) a protocol of active 76 physiotherapy for neck and shoulder muscles. This protocol included: 2.1) active 77 stretching exercises; 2.2) isometric muscle strengthening exercises; 2.3) ocular-cervical 78 kinetic re-education programme; 2.4) homework including several exercises detailed 79 below. The exercises were performed very slowly. They did not significantly increase 80 heart rate. A more detailed description of the exercises is provided in Appendix 1. 81 The participants were also asked to complete the same exercises at home for at 82 least 30 to 45 minutes once a day during the two weeks of treatment. To encourage 83 participants to complete the home exercises, the information provided by the 84 physiotherapist were clear and concise. After each session, the physiotherapist asked the 85 participants how they felt after the exercises performed the day before and if they had 86 any questions about them. The patients were also asked to keep a diary in order to detect 87 questions during the period between sessions and to encourage daily practice. The 88 physiotherapist explained the difference between the pain that disappears quickly after 89 the exercises are executed and the characteristics of chronic neck pain. Patients used a 90 pain diary to see the subjective effectiveness of the home exercises. They were also 91 encouraged to improve their self-care and perception of self-efficacy. This part of the 92 control intervention (home exercises) was applied one on one. 93 Application of the interferential current therapy was also one on one. The 94 experimental group also received the same supervised exercise programme as the 95 control group before their interferential current therapy treatment. The interferential 96 current therapy intervention was applied by an electrotherapy, ultrasound and combined Page 6 of 26 http://mc.manuscriptcentral.com/clinrehab Clinical Rehabilitation 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
For Peer Review 5 97 therapy device using SONOPULS 692® (brand: ENRAF NONIUS). The interferential 98 current therapy used the following parameters: bipolar application method with 4000 Hz 99 carrier frequency and 60 Hz amplitude modulated frequency, with a modulation 100 frequency of 90 Hz, with five 10 cm2 electrodes placed in opposition to the neck (C5101 C6-C7) for 25 minutes. The intensity (voltage) of the interferential current therapy was 102 adapted to the sensitivity of each patient. During the treatment time, current intensity 103 was increased between three to five times, within the limits of patients' perception 104 without exceeding excitability and pain thresholds. The increased intensity was intended 105 to retard the apparition of accommodative phenomena.13,14 106 Sociodemographic and clinical data were recorded using an ad hoc questionnaire 107 prepared by the researchers. These data were provided by the patients and collected 108 from their medical report. Body Mass Index was also calculated and recorded at 109 baseline. Assessments were completed at two points: at baseline (before randomisation), 110 and posttreatment. The person collecting the outcome data did not know which group 111 the patient was in, that is, it was an assessor blinded to the grouping of participants. The 112 primary outcome measure was intensity of neck pain as assessed by the 10 mm Visual 113 Analogue Scale.15 Several secondary outcome measures were also included in the 114 clinical trial. The Neck Disability Index16,17 and CORE Outcome Measure 18,19 were 115 used to evaluate the degree of disability. The CORE Outcome Measure consists of five 116 dimensions: pain, neck function, well-being in relation to specific symptoms, general 117 quality of life and disability (social and work).18,19 Anxiety and depression levels were 118 assessed by the Goldberg Scale.20,21 The Personal Psychological Apprehension Scale 119 evaluated the frequency and persistence of neuroticism/psychological apprehension by 120 ups and downs, feeling of misery, and emotional tension, among others items related to 121 the application of electrotherapy.10 The neck (or cervical) Range of Motion was Page 7 of 26 http://mc.manuscriptcentral.com/clinrehab Clinical Rehabilitation 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
For Peer Review 6 122 determined by active and passive range of motion measurements. These measurements 123 were executed in the sagittal plane (flexion and extension mobility), in the frontal plane 124 (right and left flexion), and in the transverse plane (right and left rotations). A 125 conventional two-leg goniometer (angular measurement) and a metric tape (linear 126 measurement) were used. The Range of Motion measurements were performed with the 127 subjects in a sitting position to stabilize the pelvis and the thoracic-lumbar spine.22 128 Statistical analyses were carried out by an assessor blinded to the treatment 129 allocation, using SPSS statistical software (SPSS Inc., Chicago, IL), in its version 22.0. 130 Firstly, the normal distribution of variables was verified by the Kolgomorov-Smirnov 131 test, after a descriptive analysis. The homogeneity of variances was observed by 132 Levene’s test. Linearity was evaluated by bivariate scatter plots of observed residual 133 values against the expected values. Comparisons between groups were conducted for 134 baseline demographic and clinical data using Student t-test for continuous data and chi135 square test for categorical data. 136 Separate 2x(2) mixed model analysis of variance ANOVA were used to evaluate 137 interaction time*groups, including the time effects (baseline, 2 weeks posttreatment) 138 and group effects (supervised exercise group versus interferential current therapy + 139 supervised exercise group) for each outcome measure. All analyses followed the 140 intention to treat principle and groups were analysed as randomised. Changes in 141 outcome scores between and within groups were measured by Student t-tests for paired 142 or independent samples as appropriate (95% confidence interval). Effect sizes were 143 calculated using Cohen's d coefficient. A p-value < 0.05 was considered statistically 144 significant. 145 The sample size was obtained using GPower 3.1. In order to calculate the sample 146 size, based on previous research,23 a between-group effect size at posttreatment of 1.00 Page 8 of 26 http://mc.manuscriptcentral.com/clinrehab Clinical Rehabilitation 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
For Peer Review 13 287 9. Lindsay DM, Dearness J, McGinley CC. Electrotherapy usage trends in private 288 physiotherapy practice in Alberta. Physiother Canada Physiothérapie Canada. 1995; 289 47(1):30–4. 290 10. Albornoz Cabello M, Rebollo Roldán J, García Pérez R. Escala de Aprensión 291 Psicológica Personal (EAPP) en Fisioterapia (Personal PsychologicalAppraisalScale 292 (PPAS) in Physiotherapy). Rev IberoamFisioter y Kinesiol. 2005; 8(2): 77–87. 293 11. Binder A. The diagnosis and treatment of nonspecific neck pain and whiplash. Eura 294 Medicophys. 2007; 43(1):79–89. 295 12. Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, et al. 296 CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel 297 group randomised trials. Int J Surg. 2012; 10(1):28–55. 298 13. Hurley DA, Minder PM, McDonough SM, Walsh DM, Moore AP, Baxter DG. 299 Interferential therapy electrode placement technique in acute low back pain: A 300 preliminary investigation. Arch Phys Med Rehabil. 2001;82(4):485–93. 301 14. Albornoz M, Martín J. Estimulación eléctrica transcutánea y neuromuscular 302 (Transcutaneous and neuromuscular electrical stimulation). Spain. Editorial Elsevier, 303 2010. 304 15. Jensen MP, Turner JA, Romano JM, Fisher LD. Comparative reliability and validity 305 of chronic pain intensity measures. Pain. 1999; 83: 157-62. 306 16. Cleland JA, Fritz JM, Whitman JM, Palmer JA. The reliability and construct 307 validity of the Neck Disability Index and patient specific functional scale in patients 308 with cervical radiculopathy. Spine (PhilaPa 1976). 2006;31(5):598–602. Page 15 of 26 http://mc.manuscriptcentral.com/clinrehab Clinical Rehabilitation 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
For Peer Review 14 309 17. Ortega JAA, Martínez ADD, Ruiz RA. Validación de una versión española del 310 Índice de Discapacidad Cervical (Validation of a Spanish version of the Cervical 311 Disability Index). Med Clin (Barc).2008; 130(3): 85–9. 312 18. Murphy DR, Lopez M. Neck and back pain specific outcome assessment 313 questionnaires in the Spanish language: a systematic literature review. Spine J. 2013; 314 13(11): 1667–74. 315 19. Fankhauser CD, Mutter U, Aghayev E, Mannion AF. Validity and responsiveness of 316 the Core Outcome Measures Index (COMI) for the neck. Eur Spine J. 2012; 21(1): 101– 317 14. 318 20. Goldberg D, Bridges K, Duncan-Jones P, Grayson D. Detecting anxiety and 319 depression in general medical settings. BMJ. 1988; 297(6653): 897–9. 320 21. Retolaza Balsategui A, Mostajo A, de la Rica J, Díaz de Garramiola A, Pérez de 321 Loza J, Aramberri I, et al. Validación del Cuestionario de Salud General de Goldberg 322 (versión 28 ítems) en consultas de Atención Primaria (Validation of the Goldberg 323 General Health Questionnaire (28 items version) in Primary Care consultations). Rev 324 Asoc Esp Neuropsiq. 1993; 13(46): 187–94. 325 22. De-la-Llave-Rincón AI, Fernández-de-las-Peñas C, Palacios-Ceña D and Cleland 326 JA. Increased forward head posture and restricted cervical range of motion in patients 327 with carpal tunnel syndrome. J Orthop Sports PhysTher. 2009; 39: 658–664. 328 23. Acedo AA, Antunes ACL, Dos Santos AB, De Olveira CB, Dos Santos CT, 329 Colonezi GLT, et al. Upper trapezius relaxation induced by tens and interferential 330 current in computer users with chronic nonspecific neck discomfort: An 331 electromyographic analysis. J Back Musculoskelet Rehabil. 2015; 28(1): 19–24. Page 16 of 26 http://mc.manuscriptcentral.com/clinrehab Clinical Rehabilitation 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
For Peer Review 15 332 24. Escortell-Mayor E, Riesgo-Fuertes R, Garrido-Elustondo S, Asúnsolodel Barco A, 333 Díaz-Pulido B, Blanco-Díaz M, Bejerano-Álvarez E. Primary care randomized clinical 334 trial: Manual therapy effectiveness in comparison with TENS in patients with neck pain. 335 Man Ther. 2011; 16: 66-73. 336 25. González-Iglesias J, Fernández-de-las-Peñas C, Cleland JA, Alburquerque-Sendín 337 F, et al. Inclusion of thoracic spine thrust manipulation into an electro-therapy / thermal 338 program for the management of patients with acute mechanical neck pain: A 339 randomized clinical trial. Man Ther. 2009; 14(3): 306–13. 340 26. Seo HG, Bang MS, Chung SG, Jung SH, Lee S-U, Han SC, et al. Effect of Electrical 341 Stimulation on Botulinum Toxin: a Therapy in Patients With Chronic Myofascial Pain 342 Syndrome: A 16-Week Randomized Double-Blinded Study. Arch Phys Med Rehabil. 343 2013; 94(3): 412–8. 344 27. Rodríguez-Fernández ÁL, Garrido-Santofimia V, Güeita-Rodríguez J, Fernández345 De-Las-Peñas C. Effects of Burst-Type Transcutaneous Electrical Nerve Stimulation on 346 Cervical Range of Motion and Latent Myofascial Trigger Point Pain Sensitivity. Arch 347 Phys Med Rehabi. 2011; 92: 1353–8. 348 28. Goode AP, Freburger J, Carey T, Carolina N, Hill C. Prevalence, Practice Patterns, 349 and Evidence for Chronic Neck Pain. Arthritis Care Res (Hoboken). 2010; 62(11): 350 1594–601. 351 Page 17 of 26 http://mc.manuscriptcentral.com/clinrehab Clinical Rehabilitation 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
For Peer Review 16 352 Table 1. M (SD), absolute frequency of patients’ characteristics and between-groups 353 differences at baseline. Sociodemographic and clinical characteristics Electrical stimulation therapy + Supervised exercises Group M (SD)/ n (%) N = 42 Supervised exercises Group M (SD)/ n (%) N = 42 Mean age 49.81 (9.52) 44.52 (11.77) Weight (kg) 74.50 (16.74) 70.19 (10.69) Height (cm) 1.68 (0.08) 1.67 (0.83) Body mass index 26.40 (5.16) 25.46 (4.94) Sex Females 29 33 Male 13 9 Civil Status Married 37 29 Single 1 10 Divorced 3 3 Widower 1 0 Educational level No studies 0 0 School level 16 25 Bachelor level 22 11 University level 4 6 Pharmacologic treatment Yes 25 30 Not 17 12 354 M (SD) = Mean (Standard deviation); n = absolute frequency. 355 356 Page 18 of 26 http://mc.manuscriptcentral.com/clinrehab Clinical Rehabilitation 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
For Peer Review 17 357 Table 2. Baseline, post-treatment, pre-post-treatment changes and between-group differences 358 (95% confidence interval) for perceived disability, anxiety and depression symptoms, 359 psychological apprehension, and pain intensity. Outcome/ Group Baseline M (SD) Two weeks Posttreatment M (SD) Within-Group Score Changes Between-Group Score Changes Pain Intensity (VAS) (0-10) Interferential current therapy group 6.60 (1.30) 2.73 (1.24) 3.86 (3.48, 4.25)** -2.27 (-2.88, -1.65)** Supervised exercises group 6.23 (1.49) 4.99 (1.56) 1.23 (0.87, 1.59)** NDI Interferential current therapy group 26.45 (7.65) 10.60 (4.77) 15.86 (13.88, 17.83)** -7.86 (-11.01, -4.70)** Supervised exercises group 26.10 (9.68) 18.45 (9.04) 7.64 (5.70, 9.59)** COM Interferential current therapy group 39.48 (11.91) 19.18 (9.99) 20.30 (16.26, 24.33)** -15.94 (-21.07, -10.81)** Supervised exercises group 43.21 (13.46) 35.12 (13.36) 8.10 (6.30, 9.90)** Total Goldberg Interferential current therapy group 9.90 (4.74) 6.17 (4.27) 3.74 (2.85, 4.63)** -1.74 (-3.73, 0.25)** Supervised exercises group 8.33 (4.72) 7.90 (4.87) 0.43 (-0.14, 0.99) Goldberg – Anxiety subscale Interferential current therapy group 5.86 (2.73) 4.05 (2.93) 1.81 (1.03, 2.59)** -0.52 (-1.79, 0.74)** Supervised exercises group 5.10 (2.60) 4.57 (2.91) 0.52 (-0.08, 1.13) Goldberg – Depression subscale Page 19 of 26 http://mc.manuscriptcentral.com/clinrehab Clinical Rehabilitation 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
For Peer Review 18 360 M (SD) = Mean (Standard deviation); VAS = Visual Analogue scale; NDI = Neck 361 Disability Index; COM = Core Outcome Measure; EAPP = Personal Psychological 362 Apprehension scale. 363 *p<0.05, **p<0.01. 364 365 366 367 368 Interferential current therapy group 3.93 (2.81) 3.02 (2.40) 0.90 (0.35, 1.46)** 0.10 (-1.01, 1.20) Supervised exercises group 3.19 (2.66) 2.93 (2.67) 0.26 (-0.17, 0.69) EAPP Interferential current therapy group 30.50 (10.56) 28.17 (9.61) 2.33 (1.08, 3.59)** 1.88 (-2.63, 6.40)** Supervised exercises group 26.62 (10.41) 26.29 (11.14) 0.33 (-0.89, 1.57) Page 20 of 26 http://mc.manuscriptcentral.com/clinrehab Clinical Rehabilitation 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
For Peer Review 19 369 Table 3. Baseline, post-treatment, pre-post-treatment changes and between-group differences 370 (95% confidence interval) for neck range of motion. Outcome/ Group Baseline M (SD) Two weeks Posttreatment M (SD) Within-Group Score Changes Between-Group Score Changes Active flexion (tape) Interferential current therapy group 4.77 (1.81) 3.94 (1.44) 0.82 (0.44, 1.21)** -0.15 (-0.83, 0.52) Supervised exercises group 6.52 (10.79) 4.10 (1.67) 2.42 (-0.95, 5.79) Passive flexion (tape) Interferential current therapy group 3.74 (1.77) 2.50 (1.34) 1.24 (0.88, 1.61)** -0.54 (-1.18, 0.10) Supervised exercises group 3.93 (1.71) 3.03 (1.60) 0.89 (0.57, 1.22)** Active flexion (goniometer) Interferential current therapy group 37.05 (9.28) 40.45 (10.88) -3.41 (-5.49, -1.32)** 1.14 (-3.67, 5.95) Supervised exercises group 35.50 (10.06) 39.31 (11.29) -3.81 (-5.10, -2.52)** Passive flexion (goniometer) Interferential current therapy group 41.14 (10.43) 46.95 (11.87) -5.81 (-7,49, -4,13)** 3.19 (-1.79, 8.17) Supervised exercises group 39.45 (11.07) 43.76 (11.05) -4.31 (-5.85, -2.77)** Active Extension (tape) Interferential current therapy group 17.13 (2.92) 17.05 (2.82) 0.08 (-0.94, 1.09) 0.70 (-0.76, 2.15) Supervised exercises group 17.08 (1.89) 16.36 (3.81) 0.72 (-0.42, 1.87) Passive Extension (tape) Interferential current therapy group 18.12 (3.42) 18.06 (2.99) 0.06 (-1.11, 1.24) 0.81 (-0.69, 2.31) Page 21 of 26 http://mc.manuscriptcentral.com/clinrehab Clinical Rehabilitation 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
For Peer Review 20 Supervised exercises group 17.94 (1.76) 17.25 (3.88) 0.69 (-0.52, 1.89) Active Extension (goniometer) Interferential current therapy group 43.05 (6.51) 43.81 (9.13) -0.76 (-2.82, 1.30) -1.81 (-5.79, 2.17) Supervised exercises group 44.40 (7.77 45.62 (9.22) -1.21 (-2.08, -0.35)** Passive Extension (goniometer) Interferential current therapy group 48.12 (7.22) 49.33 (10.63) -1.21 (-3.62, 1.19) -0.76 (-5.20, 3.68) Supervised exercises group 49.02 (8.80) 50.10 (9.81) -1.07 (-1.83, -0.31)** Active right lateral-flexion (tape) Interferential current therapy group 9.42 (2.76) 8.83 (2.07) 0.59 (-0.04, 1.22) 0.56 (-0.43, 1.55) Supervised exercises group 8.92 (2.42) 8.27 (2.48) 0.65 (0.44, 0.86)** Passive right lateralflexion (tape) Interferential current therapy group 8.70 (2.38 7.79 (2.05) 0.91 (0.53, 1.29)** 0.64 (-0.23, 1.51) Supervised exercises group 8.05 (2.29) 7.15 (1.98) 0.90 (0.63, 1.17)** Active right lateral-flexion (goniometer) Interferential current therapy group 30.62 (6.89) 33.21 (5.57) -2.60 (-4.57, -0.62)* 0.74 (-1.83, 3.31) Supervised exercises group 30.02 (5.96) 32.48 (6.26) -2.45 (-3.23, -1.68)** Passive right lateralflexion (goniometer) Interferential current therapy group 34.57 (6.63) 38.19 (6.17) -3.62 (-5.41, -1.83)** 1.38 (-1.42, 4.18) Supervised exercises group 33.24 (5.70) 36.81 (6.70) -3.57 (-4.69, -2.45)** Active left lateral-flexion (tape) Page 22 of 26 http://mc.manuscriptcentral.com/clinrehab Clinical Rehabilitation 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
For Peer Review 21 Interferential current therapy group 9.69 (2.59) 8.75 (2.29) 0.95 (0.59, 1.30)** 0.55 (-0.46, 1.57) Supervised exercises group 8.75 (2.29) 8.19 (2.38) 0.80 (0.58, 1.03)** Passive left lateral-flexion (tape) Interferential current therapy group 8.40 (2.34) 7.75 (2.08) 0.85 (0.37, 1.33)** 0.48 (-0.36, 1.32) Supervised exercises group 7.76 (2.19) 7.07 (1.80) 0.70 (0.36, 1.03)** Active left lateral-flexion (goniometer) Interferential current therapy group 31.67 (7.08) 34.05 (5.72) -2.38 (-3.87, -0.90)** 0.95 (-1.66, 3.57) Supervised exercises group 29.79 (5.70) 33.10 (6.31) -3.31 (-4.20, -2.42)** Passive left lateral-flexion (goniometer) Interferential current therapy group 36.48 (7.74) 39.71 (6.38) -3.24 (-4.94, -1.54)** 2.00 (-0.99, 4.99) Supervised exercises group 33.83 (5.98) 37.71 (7.36) -3.88 (-5.35, -2.42)** Active right rotation (tape) Interferential current therapy group 8.79 (2.57) 7.96 (2.33) 0.84 (0.40, 1.29)** 0.42 (-0.70, 1.55) Supervised exercises group 7.87 (2.17) 7.53 (2.84) 0.34 (-0.35, 1.03) Passive right rotation (tape) Interferential current therapy group 7.74 (2.28) 6.74 (2.24) 0.99 (0.40, 1.28)** 0.64 (-0.27, 1.55) Supervised exercises group 6.86 (1.97) 6.10 (1.95) 0.75 (0.50, 1.00)** Active right rotation (goniometer) Interferential current therapy group 53.38 (12.07) 58.81 (9.88) -5.43 (-8.55, -2.31)** 1.81 (-2.31, 5.93)** Supervised exercises group 54.81 (8.27) 57.00 (9.08) -2.19 (-3.10, -1.28)** Page 23 of 26 http://mc.manuscriptcentral.com/clinrehab Clinical Rehabilitation 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
For Peer Review 22 371 M (SD) = Mean (Standard deviation). 372 *p<0.05, **p<0.01. 373 374 Passive right rotation (goniometer) Interferential current therapy group 60.60 (9.43) 66.19 (10.39) -5.60 (-7.51, -3.68)** 3.38 (-0.99, 7.76)** Supervised exercises group 59.52 (8.64) 62.81 (9.75) -3.29 (-4.36, -2.12)** Active left rotation (tape) Interferential current therapy group 8.94 (2.34) 8.07 (2.26) 0.87 (0.52, 1.22)** 0.82 (-0.09, 1.73) Supervised exercises group 8.16 (1.99) 7.25 (1.92) 0.91 (0.58, 1.24)** Passive left rotation (tape) Interferential current therapy group 7.89 (2.26) 6.81 (2.26) 1.08 (0.72, 1.45)** 0.88 (-0.01, 1.76) Supervised exercises group 6.92 (1.89) 5.93 (1.78) 0.99 (0.70, 1.27)** Active left rotation (goniometer) Interferential current therapy group 58.55 (10.12) 61.95 (9.52) -3.41 (-5.05, -1.76)** 4.17 (0.01, 8.25) Supervised exercises group 54.21 (8.36) 57.79 (9.29) -3.57 (-4.83, -2.32)** Passive left rotation (goniometer) Interferential current therapy group 64.31 (10.51) 68.93 (10.32) -4.62 (-6.11, -3.12)** 5.07 (0.67, 9.47) Supervised exercises group 60.29 (8.92) 63.86 (9.96) -3.57 (-4.93, -2.21)** Page 24 of 26 http://mc.manuscriptcentral.com/clinrehab Clinical Rehabilitation 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60