Chronic Non-specific Neck PainNCT05992051
Effects of Online Exercise Intervention on Physical and Mental Conditions in Young Adults With Chronic Neck Pain
A study testing Exercise Therapy in people with Chronic Non-specific Neck Pain, run by Beijing Sport University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Chronic Non-specific Neck Pain
- What is being tested?
- Exercise Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2021to 30 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
School of Sports Medicine and Rehabilitation, Beijing Sport University
Beijing, Beijing Municipality, 100091
About this study
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.
Read the 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
- Being tested
- Exercise Therapy
- Keywords
- chronic neck pain, non-specific neck pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| online exercise therapy | Experimental | 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 Receives: Behavioral: Exercise Therapy |
| conventional exercise therapy | Active comparator | 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 Receives: Behavioral: Exercise Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analog scale (VAS)
A Visual Analogue Scale (VAS) is one of the pain rating scales used for the first time in 1921 by Hayes and Patterson. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. In this study, the VAS is used to measure the average and maximum neck pain level. The outcome is measured with 100-mm visual analog scale (VAS), in which 0 indicating no pain and 10.0 indicating unbearable pain.
Measured: measured at baseline prior to randomization and after the 6-week intervention period
Neck Disability Index (NDI)
The Neck Disability Index (NDI) is a self-report questionnaire used to determine how neck pain affects a patient's daily life and to assess the self-rated disability of patients with neck pain. The NDI consists of 10 items related to pain intensity, headache, concentration and different physical activities. The score of each item ranges from 0 to 5. The maximum total score is 50 and the final score will be standardized into 0 to 100. The higher the score of the NDI, the more severe the neck dysfunction is.
Measured: measured at baseline prior to randomization and after the 6-week intervention period
Secondary outcomes (2)
Hospital Anxiety and Depression Scale (HADS)
The Hospital Anxiety and Depression Scale (HADS) was devised 30 years ago by Zigmond and Snaith to measure anxiety and depression in a general medical population of patients. In this study, it was used to measure the mental condition of participants. The scale comprises 14 questions which related 2 underlying sub-scale dimensions, anxiety (HADS-A) and depression (HADS-D) respectively. Each subscale has 7 items and each item is scored with 0-3 points. The minimum and maximum values of the HADS are 0 and 42. The higher the score, the more severe the condition is. The minimum and maximum values of the subscales are 0 and 21, and higher scores mean a worse outcome. Those with score ≥8 on HADS-A or HADS-D were considered to be at high risk of having anxiety or depression.
Measured: measured at baseline prior to randomization and after the 6-week intervention period
Work Limitations Questionnaire (WLQ)
The Work Limitations Questionnaire (WLQ-25) is a 25-item objective measure used to evaluate at-work disability and productivity loss. It is a self-reported tool to evaluate the degree of difficulty in completing 25 specific tasks in the past 2 weeks. The score of each task ranges from 1 (no difficulty) to 5 (always having difficulties). The minimum and maximum values of the WLQ are 25 and 125. The higher the score, the lower the work efficiency is.
Measured: measured at baseline prior to randomization and after the 2-week, 4-week, 6-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start15 Apr 2021
- Primary completion1 Aug 2021
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Non-specific Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Sport University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JINGHUA QIAN, Beijing Sport University
- Investigators
- Jinghua Qian, Doctor, Study chair, Beijing Sport University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05992051
- Sponsor's protocol ID
- 20212069
- Status last verified
- Aug 2023
- First submitted
- 29 Jul 2023
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Online Exercise Intervention on Physical and Mental Conditions in Young Adults With Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT05992051
- Acronym / sponsor ID
- 20212069
- Conditions
- Chronic Non-specific Neck Pain
- Keywords
- chronic neck pain, non-specific neck pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Beijing Sport UniversityUniversity, hospital or other
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 15 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| online exercise therapy | Experimental | Behavioral: Exercise TherapyThe 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 |
| conventional exercise therapy | Active comparator | Behavioral: Exercise TherapyParticipants 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise TherapyExercise 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. | Behavioural | conventional exercise therapy, online exercise therapy |
Primary outcome
visual analog scale (VAS)
Time frame: measured at baseline prior to randomization and after the 6-week intervention period
A Visual Analogue Scale (VAS) is one of the pain rating scales used for the first time in 1921 by Hayes and Patterson. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. In this study, the VAS is used to measure the average and maximum neck pain level. The outcome is measured with 100-mm visual analog scale (VAS), in which 0 indicating no pain and 10.0 indicating unbearable pain.
Neck Disability Index (NDI)
Time frame: measured at baseline prior to randomization and after the 6-week intervention period
The Neck Disability Index (NDI) is a self-report questionnaire used to determine how neck pain affects a patient's daily life and to assess the self-rated disability of patients with neck pain. The NDI consists of 10 items related to pain intensity, headache, concentration and different physical activities. The score of each item ranges from 0 to 5. The maximum total score is 50 and the final score will be standardized into 0 to 100. The higher the score of the NDI, the more severe the neck dysfunction is.
2 secondary outcomes
Hospital Anxiety and Depression Scale (HADS)
Time frame: measured at baseline prior to randomization and after the 6-week intervention period
Work Limitations Questionnaire (WLQ)
Time frame: measured at baseline prior to randomization and after the 2-week, 4-week, 6-week intervention period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jinghua Qian, Doctor study chair
Beijing Sport University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Therapy in people with Chronic Non-specific Neck Pain, run by Beijing Sport University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analog scale (VAS) (time frame: measured at baseline prior to randomization and after the 6-week intervention period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2023.