Mechanical Neck PainNCT05684809
Efficacy of Mobilization With Post- Isometric Relaxation in Neck Pain Associated With Myofascial Trigger Points
A study testing Post Isometric relaxation Technique (PIR), Cervical Mobilization (CM) and conventional treatment in people with Mechanical Neck Pain, run by Najran University at 2 sites in Saudi Arabia.
Trial summary
purpose of the study: to determine the effectiveness of cervical mobilization with PIR in reducing pain and improving neck ROM and function in people with mechanical neck pain associated with MTrPs Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Mechanical Neck Pain
- What is being tested?
- Post Isometric relaxation Technique (PIR), Cervical Mobilization (CM) and conventional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 2 sitesSaudi Arabia
- Study dates
- 30 Oct 2022to 15 Feb 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age 20-40 years,
- having mechanical neck pain located in the neck or scapular regions along with 1-2 MTrPs which,
- on palpation replicated their chief complaints in the upper Trapezius muscle (unilateral).
Who cannot join
- known cases of fibromyalgia syndrome,
- cervical radiculopathy or myelopathy,
- history of cervical spine surgery,
- congenital or acquired postural deformity, presence of MTrPs in bilateral upper Trapezius muscles,
- patients who received any treatment for their pain one month prior to the study.
Trial locations and contacts
2 sites in 1 country.
Saudi Arabia2 sites
Hashim Ahmed
Najran, Najran Region, 1988
Hashim Ahmed
Najran, Najran Region, 66262
About this study
Official title: Efficacy of Cervical Mobilization With Post Isometric Relaxation in Managing Mechanical Neck Pain Associated With Myofascial Trigger Points: a Randomized Comparative Study
purpose of the study: to determine the effectiveness of cervical mobilization with PIR in reducing pain and improving neck ROM and function in people with mechanical neck pain associated with MTrPs
Read the detailed description
This study will be based on a randomized controlled design which will be comparative in nature. Participants will be recruited using the convenience sampling method and will be randomly divided into two groups A and B respectively. Thirty participants of mechanical neck pain associated with upper Trapezius trigger point pain will be recruited from the Physiotherapy department, at the Najran University, Saudi Arabia. Study objectives and procedure will be properly explained and written informed consent will be obtained at the beginning of the study. All the participants will be randomly assigned into two equal groups A and B.
Group A will be receiving the hot pack, active Stretching, isometric exercise intervention, and PIR technique while group B will receive the hot pack, active Stretching, isometric exercise intervention, and cervical Mobilization.
- Conditions
- Mechanical Neck Pain
- Being tested
- Post Isometric relaxation Technique (PIR), Cervical Mobilization (CM), conventional treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post Isometric relaxation Technique (PIR)Other
In PIR intervention, the patients were requested to lie down in a supine position and their neck was in a lateral flexion to the opposite side so that the target upper Trapezius muscle fibers would be in a lengthened position. The therapist performed a moderate isometric contraction (approximately 75% of maximal) of upper Trapezius muscles, held it for 5 seconds, then relaxed for 3 seconds before moving the cervical spine into the new barrier. In each session, this technique was repeated for four times, on alternate days for three weeks.
Cervical Mobilization (CM)Other
Cervical Mobilization was delivered in prone lying with their foreheads resting comfortably on his hands, and the chin was tucked in.The treatment session was done on alternate days (3 days a week) for 3 weeks, hence the total number of sessions were 9.
conventional treatmentOther
Hot Pack was given for twenty minutes, slow sustained stretching exercises ( 20 second hold, 10-second relaxation) were given, and isometric exercise of the neck((10 repetitions of two sets with 10 seconds hold) alternate days for three weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | in addition to Conventional treatment, PIR and cervical mobilization were given Receives: Other: Post Isometric relaxation Technique (PIR); Other: Cervical Mobilization (CM); Other: conventional treatment |
| Group B | Active comparator | in addition to Conventional treatment, PIR were given Receives: Other: Post Isometric relaxation Technique (PIR); Other: conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
The pain intensity was assessed Using a numeric pain rating scale (NPRS), Its a 11 point scale, where zero indicates no pain and 10 indicates severe pain
Measured: 3 Weeks
Neck Disability Index
The Neck Disability was assessed using a neck disability index (NDI) questionnaire, the minimum value 0- and the maximum value is 50
Measured: 3 Weeks
Range of Motion
The Neck Side Flexion range of motion was assessed using cervical range of motion(CROM) device
Measured: 3 Weeks
Pain Pressure Threshold
The Pain Pressure Threshold (PPT) was assessed using an algometer algometer
Measured: 3 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start30 Oct 2022
- Primary completion28 Jan 2023
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Najran University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hashim Ahmed, Najran University
- Investigators
- Hashim Ahmed, PhD, Principal investigator, Najran University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05684809
- Sponsor's protocol ID
- 444-42-20993-DS
- Status last verified
- Mar 2023
- First submitted
- 5 Jan 2023
- Last updated
- 24 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Cervical Mobilization With Post Isometric Relaxation in Managing Mechanical Neck Pain Associated With Myofascial Trigger Points: a Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT05684809
- Acronym / sponsor ID
- 444-42-20993-DS
- Conditions
- Mechanical Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Najran UniversityUniversity, hospital or other
- Study start
- 30 Oct 2022 (actual)
- Primary completion
- 28 Jan 2023 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 13 Jan 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.
purpose of the study: to determine the effectiveness of cervical mobilization with PIR in reducing pain and improving neck ROM and function in people with mechanical neck pain associated with MTrPs
Detailed description
This study will be based on a randomized controlled design which will be comparative in nature. Participants will be recruited using the convenience sampling method and will be randomly divided into two groups A and B respectively. Thirty participants of mechanical neck pain associated with upper Trapezius trigger point pain will be recruited from the Physiotherapy department, at the Najran University, Saudi Arabia. Study objectives and procedure will be properly explained and written informed consent will be obtained at the beginning of the study. All the participants will be randomly assigned into two equal groups A and B.
Group A will be receiving the hot pack, active Stretching, isometric exercise intervention, and PIR technique while group B will receive the hot pack, active Stretching, isometric exercise intervention, and cervical Mobilization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Post Isometric relaxation Technique (PIR), Other: Cervical Mobilization (CM), Other: conventional treatmentin addition to Conventional treatment, PIR and cervical mobilization were given |
| Group B | Active comparator | Other: Post Isometric relaxation Technique (PIR), Other: conventional treatmentin addition to Conventional treatment, PIR were given |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age 20-40 years,
- having mechanical neck pain located in the neck or scapular regions along with 1-2 MTrPs which,
- on palpation replicated their chief complaints in the upper Trapezius muscle (unilateral).
Key exclusion criteria (5 listed)
- known cases of fibromyalgia syndrome,
- cervical radiculopathy or myelopathy,
- history of cervical spine surgery,
- congenital or acquired postural deformity, presence of MTrPs in bilateral upper Trapezius muscles,
- patients who received any treatment for their pain one month prior to the study.
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 |
|---|---|---|
| Post Isometric relaxation Technique (PIR)In PIR intervention, the patients were requested to lie down in a supine position and their neck was in a lateral flexion to the opposite side so that the target upper Trapezius muscle fibers would be in a lengthened position. The therapist performed a moderate isometric contraction (approximately 75% of maximal) of upper Trapezius muscles, held it for 5 seconds, then relaxed for 3 seconds before moving the cervical spine into the new barrier. In each session, this technique was repeated for four times, on alternate days for three weeks. | Other | Group A, Group B |
| Cervical Mobilization (CM)Cervical Mobilization was delivered in prone lying with their foreheads resting comfortably on his hands, and the chin was tucked in.The treatment session was done on alternate days (3 days a week) for 3 weeks, hence the total number of sessions were 9. | Other | Group A |
| conventional treatmentHot Pack was given for twenty minutes, slow sustained stretching exercises ( 20 second hold, 10-second relaxation) were given, and isometric exercise of the neck((10 repetitions of two sets with 10 seconds hold) alternate days for three weeks. | Other | Group A, Group B |
Primary outcome
Pain intensity
Time frame: 3 Weeks
The pain intensity was assessed Using a numeric pain rating scale (NPRS), Its a 11 point scale, where zero indicates no pain and 10 indicates severe pain
Neck Disability Index
Time frame: 3 Weeks
The Neck Disability was assessed using a neck disability index (NDI) questionnaire, the minimum value 0- and the maximum value is 50
Range of Motion
Time frame: 3 Weeks
The Neck Side Flexion range of motion was assessed using cervical range of motion(CROM) device
Pain Pressure Threshold
Time frame: 3 Weeks
The Pain Pressure Threshold (PPT) was assessed using an algometer algometer
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 24 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Mechanical Neck Pain
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The Association Between Smartphone Overuse and Mechanical Neck Pain Among Galala University Students
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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.
Hashim Ahmed, PhD principal investigator
Najran University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Post Isometric relaxation Technique (PIR), Cervical Mobilization (CM) and conventional treatment in people with Mechanical Neck Pain, run by Najran University at 2 sites 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 3 inclusion and 5 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 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Pain intensity (time frame: 3 Weeks). The study lists 4 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 24 Mar 2023.