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

NCT ID: NCT05992051

Last Updated: 2023-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-15
• Study Completion Date: 2023-01-30

Brief Summary

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.

Detailed 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.

Conditions

Chronic Non-specific Neck Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

online exercise therapy

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

Group Type: EXPERIMENTAL

Exercise Therapy

Intervention Type: BEHAVIORAL

Exercise therapy is considered as the integral component of interventions for chronic non-specific neck pain. It includes different type resistance training, range of motion exercises and stretching exercises to improve neck condition and release symptoms.

conventional exercise therapy

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

Group Type: ACTIVE_COMPARATOR

Exercise Therapy

Intervention Type: BEHAVIORAL

Exercise therapy is considered as the integral component of interventions for chronic non-specific neck pain. It includes different type resistance training, range of motion exercises and stretching exercises to improve neck condition and release symptoms.

Interventions

Exercise Therapy

Exercise therapy is considered as the integral component of interventions for chronic non-specific neck pain. It includes different type resistance training, range of motion exercises and stretching exercises to improve neck condition and release symptoms.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Sport University

OTHER

Sponsor Role: lead

Responsible Party

JINGHUA QIAN

Professor, deputy dean of School of Sports Medicine and Rehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jinghua Qian, Doctor

Role: STUDY_CHAIR

Beijing Sport University

Locations

School of Sports Medicine and Rehabilitation, Beijing Sport University

Beijing, Beijing Municipality, China

Countries

China

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

20212069

Identifier Type: -

Identifier Source: org_study_id