Clinical trial NCT05992051: Effects of Online Exercise Intervention on Physical and Mental Conditions in Young Adults With Chronic Neck Pain
Official title: Effects of Online Exercise Intervention on Physical and Mental Conditions in Young Adults With Chronic Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Non-specific Neck Pain
Keywords: chronic neck pain
non-specific neck pain
Lead sponsor: Beijing Sport University
Sponsor class: OTHER
First posted: 2023-08-15
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial with 39 adults with self-reported chronic neck pain recruited. They were randomly assigned into two groups. The experimental group received online exercise therapy and the control group received conventional exercise therapy.

Participants in both groups completed the same exercise program three times a week for six weeks. Visual analogue scale (VAS), the Neck Disability Index (NDI), Work Limitations Questionnaire (WLQ) and The Hospital Anxiety and Depression Scale (HADS) and its subscales were evaluated. Participants were assessed at baseline and at 6 weeks while the changes in WLQ were assessed biweekly. To ensure the effectiveness of online exercise therapy, therapists delivered the online exercise 3 times a week for 6 weeks, with videoconferencing once a week and posting of exercise record on social media twice a week.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: visual analog scale (VAS)
timeFrame: measured at baseline prior to randomization and after the 6-week intervention period
measure: Neck Disability Index (NDI)
timeFrame: measured at baseline prior to randomization and after the 6-week intervention period
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: measured at baseline prior to randomization and after the 6-week intervention period
measure: Work Limitations Questionnaire (WLQ)
timeFrame: measured at baseline prior to randomization and after the 2-week, 4-week, 6-week intervention period
Other outcomes:
Locations:
city: Beijing
country: China
facility: School of Sports Medicine and Rehabilitation, Beijing Sport University
state: Beijing
Study officials:
affiliation: Beijing Sport University
name: Jinghua Qian, Doctor
role: STUDY_CHAIR
References: