NCT05992051

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 15, 2023

Completed
Last Updated

August 15, 2023

Status Verified

August 1, 2023

Enrollment Period

4 months

First QC Date

July 29, 2023

Last Update Submit

August 7, 2023

Conditions

Keywords

chronic neck painnon-specific neck pain

Outcome Measures

Primary Outcomes (2)

  • 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 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 at baseline prior to randomization and after the 6-week intervention period

Secondary Outcomes (2)

  • Hospital Anxiety and Depression Scale (HADS)

    measured at baseline prior to randomization and after the 6-week intervention period

  • Work Limitations Questionnaire (WLQ)

    measured at baseline prior to randomization and after the 2-week, 4-week, 6-week intervention period

Study Arms (2)

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

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

Behavioral: Exercise Therapy

Interventions

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 therapyonline exercise therapy

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Sports Medicine and Rehabilitation, Beijing Sport University

Beijing, Beijing Municipality, 100091, China

Location

MeSH Terms

Interventions

Exercise Therapy

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Officials

  • Jinghua Qian, Doctor

    Beijing Sport University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
This experiment was performed as a single-blind experiment. The outcomes assessors are specialized personnel who do not participate in the trial intervention process and are not clear about the grouping of participants situation and the intervention situation. Outcome statistics were also performed by dedicated data analysts.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, deputy dean of School of Sports Medicine and Rehabilitation

Study Record Dates

First Submitted

July 29, 2023

First Posted

August 15, 2023

Study Start

April 15, 2021

Primary Completion

August 1, 2021

Study Completion

January 30, 2023

Last Updated

August 15, 2023

Record last verified: 2023-08

Locations