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Effects of Online Exercise Intervention on Physical and Mental Conditions in Young Adults With Chronic Neck Pain

B

Beijing Sport University

Status

Completed

Conditions

Chronic Non-specific Neck Pain

Treatments

Behavioral: Exercise Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT05992051
20212069

Details and patient eligibility

About

This study aimed to compare the efficacy of online exercise therapy with conventional exercise therapy on pain, function, psychological status and work efficiency of young adults with chronic neck pain. A randomized clinical trial recruiting 39 university students with self-reported chronic neck pain was conducted. Participants were randomly assigned into the experimental group receiving online exercise therapy and the active control group receiving conventional exercise therapy. Participants in both groups completed the same exercise program 3 sessions per week for 6 weeks, with either face-to-face or online mode of delivery by physiotherapists. The pain level was assessed using visual analogue scale (VAS) based on average and at maximum intensity. Neck function and work limitations were assessed by the Neck Disability Index (NDI) and Work Limitations Questionnaire (WLQ) respectively. The Hospital Anxiety and Depression Scale (HADS) and its subscales (HADS-A and HADS-D) were used to evaluate the overall symptoms, levels of anxiety and depression respectively. Participants were assessed at baseline and at 6 weeks while the changes in WLQ were assessed biweekly.

It is hypothesized that, young adults with chronic neck pain, both the online and conventional exercise interventions could improve their pain level, neck disability, anxiety state and work efficiency, and the online exercise intervention appeared feasible as an alternative treatment option for them.

Full description

Study Title: Effects of Online Exercise Intervention on Physical and Mental Conditions in Young Adults with Chronic Neck Pain Study Population: The target participants were adults with self-reported non-specific neck pain for more than three months. They were recruited through posters and social media in the campus of the Beijing Sport University.

Study Design: The present study was an assessor blinded randomized controlled trial conducted according to the Declaration of Helsinki (World Medical Association, 2013). The Institutional Review Board of the Beijing Sport University approved the study (reference number: 2023006H). A randomized clinical trial recruiting 39 university students with self-reported chronic neck pain was conducted. Participants were randomly assigned into the experimental group receiving online exercise therapy and the active control group receiving conventional exercise therapy. Participants in both groups completed the same exercise program 3 sessions per week for 6 weeks, with either face-to-face or online mode of delivery by physiotherapists.

Sample Size Assessment: The sample size for the study was calculated to be 32 using the G*Power 3.1.9.2 (University Kiel, Germany), with an estimated effect size of group difference of 0.9 in primary outcomes and a level of significance of 0.05, statistical power of 80% with 2-tailed independent sample t test. With an anticipated dropout rate of 15%, a total of 39 participants was required.

Study Duration: Totally 8 weeks, including 1-week baseline testing, 6-week intervention and 1-week post intervention testing.

Study Intervention Description: Participants in both groups completed the same exercise program three times a week for six weeks with either face-to-face or online mode of delivery by physiotherapists.

Primary Objective: The primary objective is to study the effectiveness of online and conventional exercise therapy on pain level and function in adults with chronic neck pain. There were three primary outcomes, including average and maximum neck pain using visual analog scale (VAS), and Neck Disability Index (NDI).

Secondary Objectives: The secondary objectives are investigating the effectiveness of online and conventional exercise therapy on mental condition and working efficacy in adults with chronic neck pain. There were two secondary outcomes: anxiety and depression measured with the Hospital Anxiety and Depression Scale (HADS) and work efficiency assessed with the Work Limitations Questionnaire (WLQ).

Statistical analysis: Continuous data were expressed as means and standard deviations. Categorical data were shown as frequencies or percentages, with group comparisons performed using the Fisher exact test. The normality of continuous data was checked with the Shapiro-Wilk test. The change scores of the primary and secondary outcome variables from baseline to end of intervention between the 2 groups were compared using independent sample t test with approximate data normality. The Cohen's effect sizes of between-group comparisons were calculated. The Mann-Whitney U test was used for group comparison of non-normal continuous data. Within-group comparisons were done using paired sample t test.

Enrollment

39 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • adults between 18 and 50 years of age with neck pain (from occiput to 7th cervical vertebra) for at least 3 months
  • a score of >= 4/50 on the Neck Disability Index.

Exclusion criteria

  • adults with a history of previous neck surgery, cervical radiculopathy, acute neck injury or fracture
  • persons who had more than two hours of moderate intensity exercise or more than four hours of low intensity exercise in a week
  • persons who had received any form of physiotherapy treatment in the last 6 months.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

39 participants in 2 patient groups

online exercise therapy
Experimental group
Description:
The participants had weekly online exercise meetings with the physiotherapist in a group of 3-5 participants using online meeting app. Then the participants performed the remaining two sessions of exercises themselves weekly. All the participants of the experimental group received a package of exercise pamphlet and a video disc containing 17-minute exercise demonstrations by the physiotherapist. At baseline, the suitable elastic bands (Thera-band®) for performing the exercises were selected by testing the 15 repetitions maximum (15RM) of the Modified Brügger's Exercise (MBE) and the Modified Proprioceptive Neuromuscular Facilitation Diagonal Flexion Exercise (MPNFDFE) for the participants of both the experimental group and control group. Participants performed the following exercises three times a week for six weeks at home: A. Warm-up exercises B. Cranio-cervical flexion exercises C. Strength-endurance exercises D. Scapular stabilization exercises E. Stretching exercises
Treatment:
Behavioral: Exercise Therapy
conventional exercise therapy
Active Comparator group
Description:
Participants in the control group completed the same exercise program three times a week for six weeks with face-to-face mode delivery by physiotherapists. At baseline, the suitable elastic bands (Thera-band®) for performing the exercises were selected by testing the 15 repetitions maximum (15RM) of the Modified Brügger's Exercise (MBE) and the Modified Proprioceptive Neuromuscular Facilitation Diagonal Flexion Exercise (MPNFDFE) for the participants of both the experimental group and control group. Participants performed the following exercises three times a week for six weeks in a group of 3-5 participants in the laboratory of the Sport Medicine and Rehabilitation School of the Beijing Sport University: A. Warm-up exercises B. Cranio-cervical flexion exercises C. Strength-endurance exercises D. Scapular stabilization exercises E. Stretching exercises
Treatment:
Behavioral: Exercise Therapy

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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