Chronic PainNCT05624021
Effect of Functional Training and Isometric Exercises on Pain, ROM, and Functional Status in Patients With Neck Pain
A study testing Scapular functional training, Cervical isometric exercises and Moist heating in people with Chronic Pain, run by King Saud University at 1 site in Saudi Arabia.
Trial summary
Work-related musculoskeletal disorders have been rising fast around the globe leading to neck pain and scapular muscle dysfunction, contributing to a decrease in neck movements and functional limitations. Read more about this study
- Who is it for?
- Ages 22 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Scapular functional training, Cervical isometric exercises and Moist heating
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 23 Aug 2019to 29 Mar 2020
- 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 22 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Both male and female with aged range 22-35 years
- Neck pain of more than 3 months in duration
- Having neck pain without symptoms distal to shoulder
- Participant had not received any clinical treatment for their neck pain within 1-months, and
- Willingness to participate in the study.
Who cannot join
- Having a diagnosis of cervical spinal stenosis
- Patients with serious pathology (e.g., neoplasm, fractures and inflammatory diseases, unilateral and bilateral upper extremity radicular symptoms (cervical radiculopathy)
- Prior surgery of cervical spine
- Evidence of nerve root compression
- Pregnant women, and
- Showed poor cooperation in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Scapular Functional Training Combined With Isometric Exercises on Pain, Range of Motion, and Functions Among Individual With Mechanical Neck Pian
Work-related musculoskeletal disorders have been rising fast around the globe leading to neck pain and scapular muscle dysfunction, contributing to a decrease in neck movements and functional limitations. This study aimed to determine the efficacy of scapular functional exercise (SFE) in combination with cervical isometric exercises (CIE) on neck pain, cervical range of motion, and functional limitations among participants with chronic mechanical neck pain.The study was based on a two-arm parallel group pretest-posttest randomized control trial design. Thirty participants (females 21 and males 9; average age 28.94±3.77 years) were randomly allocated to groups A and B (n=15/group). The group's A and B participants received a common intervention, such as CIE and hot packs. However, group A received the SFE in addition to common interventions. The outcomes, such as neck pain, cervical ROM, and functional limitations, were evaluated using a numeric pain rating scale (NPRS), standard universal goniometer, and neck disability index questionnaire at baseline and 4-week post-intervention. The paired and unpaired t-test was used to analyze the intervention effects on the outcomes within-group and between-group, keeping the significance level alpha set at p<0.05.
Read the detailed description
The study hypothesised that adding the scapular functional training to the cervical isometric exercises will be equally effective than cervical isometric exercises alone on managing neck pain, cervical ROM, and functional limitations among participants with chronic mechanical neck pain. The present study is helpful for chronic mechanical neck pain patients and physiotherapist to better understand the effect of incorporation of the scapular functional training in the treatment of neck pain. Therefore, this protocol may be used as a treatment in chronic mechanical neck pain because it alleviates pain, neck disability, improving cervical range of motion in chronic mechanical neck pain.
- Conditions
- Chronic Pain
- Being tested
- Scapular functional training, Cervical isometric exercises, Moist heating
- Keywords
- Chronic pain, Range of motion, Functional limitations, Isometric exercises, Functional training
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scapular functional trainingOther
The scapular functional training consists of press up and push up plus. Press up was done in sitting position on the training bench, feet on the floor with straight arm and the palms on the edge of the bench fingers pointing forward and then lift off and dip down just in front of the seat by moving the shoulder girdle. Progression is done by placing weight on the thigh. Push-up plus exercise started from a push up position on the hand, feet or knees and keeping the torso rigid by bracing the abdominals followed by protracting the scapula as high as possible. Progression is done moving from knees to the feet or adding resistance on the upper back. The training continued for three sessions per week for four weeks.
Cervical isometric exercisesOther
The isometric neck exercises taught to all the participants to perform in neutral sitting positions at home thrice a day for 15-days continuously. The sequences of exercises were shoulder circling in clockwise and anticlockwise direction, scapular retraction with cervical retraction, neck flexion, extension, either side of lateral bending/flexion, left and right rotation. Each exercise follows a set of 10 repetition of maximum voluntary contraction with a progressive hold time of 3, 5, 7, and 10 seconds depending on the severity of pain and tolerance of the participants.
Moist heatingOther
A hydrocollator moist heat packs was applied over back of the neck in supine position to receive optimal heating. It was given for 20 minutes/day, five-day a week for four-week.
| Study group | Role | What they receive |
|---|---|---|
| SFT group | Experimental | Received Scapular functional training and cervical isometric exercises Receives: Other: Scapular functional training; Other: Cervical isometric exercises; Other: Moist heating |
| Conventional group | Active comparator | Received only isometric cervical exercises and heating Receives: Other: Cervical isometric exercises; Other: Moist heating |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neumeric pain rating scale (NPRS)
Neck pain was assessed by a nuemeric pain rating scale. It is an 11-points numeric scale marked with 0 to 10 between either end. Zero at one end and ten at the opposite end indicate no pain and unbearable/worst imaginable pain, respectively. The participants were asked to rate their current level of pain, as well as their worst and least amounts of pain in the past 24 hours.
Measured: 4 weeks
Range of Motion (ROM)
Cervical range of motion was measured by a standard universal goniometer.
Measured: 4 weeks
Functional limitations
The functional limitation due to mechanical neck pain was evaluated by a neck disability index questionnaire (NDI).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start23 Aug 2019
- Primary completion11 Dec 2019
- Study completion29 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic 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 controlled Trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Collaborators
- Majmaah University
- Responsible party
- Principal investigator, AMIR IQBAL, King Saud University
- Investigators
- Amir Iqbal, MPT, Study chair, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05624021
- Sponsor's protocol ID
- RRC-2019-17
- Status last verified
- Nov 2022
- First submitted
- 7 Nov 2022
- Last updated
- 23 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bharti N, Ahmed H, Hasan S, Iqbal A, Uddin S, Ahamed WM, Ahmad F, Mujtaba MA, Alghadir AH. Efficacy of Scapular Functional and Cervical Isometric Exercises in the Management of Chronic Mechanical Neck Pain: A Randomized Comparative Trial. Pain Res Manag. 2024 Dec 19;2024:5873384. doi: 10.1155/prm/5873384. eCollection 2024.
PubMed 39734604
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Scapular Functional Training Combined With Isometric Exercises on Pain, Range of Motion, and Functions Among Individual With Mechanical Neck Pian
- ClinicalTrials.gov ID
- NCT05624021
- Acronym / sponsor ID
- RRC-2019-17
- Conditions
- Chronic Pain
- Keywords
- Chronic pain, Range of motion, Functional limitations, Isometric exercises, Functional training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Collaborators
- Majmaah University
- Study start
- 23 Aug 2019 (actual)
- Primary completion
- 11 Dec 2019 (actual)
- Study completion
- 29 Mar 2020 (actual)
- First posted
- 21 Nov 2022 (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.
Work-related musculoskeletal disorders have been rising fast around the globe leading to neck pain and scapular muscle dysfunction, contributing to a decrease in neck movements and functional limitations. This study aimed to determine the efficacy of scapular functional exercise (SFE) in combination with cervical isometric exercises (CIE) on neck pain, cervical range of motion, and functional limitations among participants with chronic mechanical neck pain.The study was based on a two-arm parallel group pretest-posttest randomized control trial design. Thirty participants (females 21 and males 9; average age 28.94±3.77 years) were randomly allocated to groups A and B (n=15/group). The group's A and B participants received a common intervention, such as CIE and hot packs. However, group A received the SFE in addition to common interventions. The outcomes, such as neck pain, cervical ROM, and functional limitations, were evaluated using a numeric pain rating scale (NPRS), standard universal goniometer, and neck disability index questionnaire at baseline and 4-week post-intervention. The paired and unpaired t-test was used to analyze the intervention effects on the outcomes within-group and between-group, keeping the significance level alpha set at p<0.05.
Detailed description
The study hypothesised that adding the scapular functional training to the cervical isometric exercises will be equally effective than cervical isometric exercises alone on managing neck pain, cervical ROM, and functional limitations among participants with chronic mechanical neck pain. The present study is helpful for chronic mechanical neck pain patients and physiotherapist to better understand the effect of incorporation of the scapular functional training in the treatment of neck pain. Therefore, this protocol may be used as a treatment in chronic mechanical neck pain because it alleviates pain, neck disability, improving cervical range of motion in chronic mechanical neck pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled Trial
| Arm | Type | Receives |
|---|---|---|
| SFT group | Experimental | Other: Scapular functional training, Other: Cervical isometric exercises, Other: Moist heatingReceived Scapular functional training and cervical isometric exercises |
| Conventional group | Active comparator | Other: Cervical isometric exercises, Other: Moist heatingReceived only isometric cervical exercises and heating |
Who may qualify
- Ages
- 22 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Both male and female with aged range 22-35 years
- Neck pain of more than 3 months in duration
- Having neck pain without symptoms distal to shoulder
- Participant had not received any clinical treatment for their neck pain within 1-months, and
- Willingness to participate in the study.
Key exclusion criteria (6 listed)
- Having a diagnosis of cervical spinal stenosis
- Patients with serious pathology (e.g., neoplasm, fractures and inflammatory diseases, unilateral and bilateral upper extremity radicular symptoms (cervical radiculopathy)
- Prior surgery of cervical spine
- Evidence of nerve root compression
- Pregnant women, and
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 |
|---|---|---|
| Scapular functional trainingThe scapular functional training consists of press up and push up plus. Press up was done in sitting position on the training bench, feet on the floor with straight arm and the palms on the edge of the bench fingers pointing forward and then lift off and dip down just in front of the seat by moving the shoulder girdle. Progression is done by placing weight on the thigh. Push-up plus exercise started from a push up position on the hand, feet or knees and keeping the torso rigid by bracing the abdominals followed by protracting the scapula as high as possible. Progression is done moving from knees to the feet or adding resistance on the upper back. The training continued for three sessions per week for four weeks. | Other | SFT group |
| Cervical isometric exercisesThe isometric neck exercises taught to all the participants to perform in neutral sitting positions at home thrice a day for 15-days continuously. The sequences of exercises were shoulder circling in clockwise and anticlockwise direction, scapular retraction with cervical retraction, neck flexion, extension, either side of lateral bending/flexion, left and right rotation. Each exercise follows a set of 10 repetition of maximum voluntary contraction with a progressive hold time of 3, 5, 7, and 10 seconds depending on the severity of pain and tolerance of the participants. | Other | Conventional group, SFT group |
| Moist heatingA hydrocollator moist heat packs was applied over back of the neck in supine position to receive optimal heating. It was given for 20 minutes/day, five-day a week for four-week. | Other | Conventional group, SFT group |
Primary outcome
Neumeric pain rating scale (NPRS)
Time frame: 4 weeks
Neck pain was assessed by a nuemeric pain rating scale. It is an 11-points numeric scale marked with 0 to 10 between either end. Zero at one end and ten at the opposite end indicate no pain and unbearable/worst imaginable pain, respectively. The participants were asked to rate their current level of pain, as well as their worst and least amounts of pain in the past 24 hours.
Range of Motion (ROM)
Time frame: 4 weeks
Cervical range of motion was measured by a standard universal goniometer.
Functional limitations
Time frame: 4 weeks
The functional limitation due to mechanical neck pain was evaluated by a neck disability index questionnaire (NDI).
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 23 Nov 2022.
- Derived from this study: PubMed 39734604Bharti N, Ahmed H, Hasan S, Iqbal A, Uddin S, Ahamed WM, Ahmad F, Mujtaba MA, Alghadir AH. Efficacy of Scapular Functional and Cervical Isometric Exercises in the Management of Chronic Mechanical Neck Pain: A Randomized Comparative Trial. Pain Res Manag. 2024 Dec 19;2024:5873384. doi: 10.1155/prm/5873384. eCollection 2024.
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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.
Amir Iqbal, MPT study chair
King Saud 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 Scapular functional training, Cervical isometric exercises and Moist heating in people with Chronic Pain, run by King Saud University at 1 site in Saudi Arabia.
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 5 inclusion and 6 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 23 Nov 2022. 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 Saudi Arabia. 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?
Neumeric pain rating scale (NPRS) (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05624021, which also lists 1 linked publication.
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 23 Nov 2022.