Myofascial Trigger Point PainNCT03840473
Efficacy of Combination Therapies on Neck Pain & Muscle Tenderness in Patients With Upper Trapezius MTrPs
A study testing MET, ICT and Conventional Intervention in people with Myofascial Trigger Point Pain, run by King Saud University at 1 site in Saudi Arabia.
Trial summary
Myofascial pain syndrome thought to be the main cause of neck pain and shoulder muscle tenderness in the working population is characterized by myofascial trigger points (MTrPs). Read more about this study
- Who is it for?
- Ages 19 to 38 years, men only
- Conditions the study is for
- Myofascial Trigger Point Pain
- What is being tested?
- MET, ICT and Conventional Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 11 Aug 2017to 15 Feb 2018
- 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 19 to 38 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male subject diagnosed with non-specific neck pain and muscle tenderness over the upper trapezius muscle due to an active MTrP
- Age19-38 years
- Presence of a maximum of 1-2active MTrPs in a unilateral upper trapezius muscle The number of TrPs in upper trapezius is not limited to two; it may be one or may be more than two (satellite TrPs) also. However, due to time constraints of the study sessions allowed for treatment of up to 2 active MTrPs only.
Who cannot join
- Diagnosed with fibromyalgia syndrome according to the American College of Rheumatology criteria;
- Had active MTrPs in the bilateral upper trapezius muscles
- Had a history of whiplash injury or cervical spine surgery
- Were diagnosed with cervical radiculopathy or myelopathy determined by their primary health care physician
- Had accepted myofascial pain therapy within the 1 month before the study
- Showed poor cooperation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Combination Therapies on Neck Pain and Muscle Tenderness in Patients With Upper Trapezius Myofascial Trigger Points
Myofascial pain syndrome thought to be the main cause of neck pain and shoulder muscle tenderness in the working population is characterized by myofascial trigger points (MTrPs). This study aimed to examine the immediate and short-term effect of the combination of two therapeutic techniques for improving neck pain and muscle tenderness in patients with upper trapezius Myofascial Trigger points.
Read the detailed description
Purpose: Myofascial pain syndrome, thought to be the main cause of neck pain and shoulder muscle tenderness in the working population, is characterized by myofascial trigger points (MTrPs). This study aimed to examine the immediate and short-term effect of the combination of two therapeutic techniques for improving neck pain and muscle tenderness in male patients with upper trapezius active MTrPs.
Methods: This was a pretest-posttest single-blinded randomized controlled trial. Sixty male subjects with mechanical neck pain due to upper trapezius active MTrPs were recruited and randomly allocated into group A, which received muscle energy technique (MET) and ischemic compression technique (ICT)along with conventional intervention; group B, which received all the interventions of group A except ICT; and group C, which received conventional treatment only. Baseline (Pr), immediate post-intervention (Po), and 2-week follow-up (Fo) measurements were made for all variables. Pain intensity and pressure pain threshold (PPT)were assessed by a visual analog scale (VAS) and pressure threshold meter, respectively. All three groups received their defined intervention plans only. Repeated-measures analysis of variance was used to perform intra- inter-group analyses. Cohen's d test was used to assess the effect size of the applied interventions within the groups.
- Conditions
- Myofascial Trigger Point Pain
- Being tested
- MET, ICT, Conventional Intervention
- Keywords
- Neck pain, Upper trapezius muscle, Myofascial trigger points, Muscle tenderness, Pain pressure threshold
- Medical subject headings
- Myofascial Pain Syndromes, Neck Pain, Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
METBehavioural
The patient was in a supine position with the cervical spine in the opposite lateral flexion to the treating part so that the upper trapezius muscle fibers were in a lengthened position.19 The moderate isometric contraction (approximately 75% of maximal) of the upper trapezius muscles was elicited for a period of 5 seconds followed by 3 seconds of relaxation while reaching the new barrier. The technique was repeated four times in each session.
ICTBehavioural
The patient lying in the supine position with the cervical spine in opposite lateral flexion to the treating part so that the upper trapezius muscle fibers were kept in a lengthened position.18,22 The physiotherapist applied gradually increasing pressure to the MTrPs until the subject perceived the first noticeable pain. At that moment, the pressure was maintained until the discomfort and/or pain eased by around 50% as perceived by the patient, at which time the pressure was increased until the discomfort appeared again. This process was maintained for 90 seconds.
Conventional InterventionBehavioural
Hot packs (75°C) for 20 minutes and active stretching exercises for the upper trapezius muscle (slow, 5 repetitions per session, 10-second hold and 10-second relaxation between two repetitions). Active stretching exercises were done by all the participants under the supervision of the physical therapist. This approach was standardized for all participants.
| Study group | Role | What they receive |
|---|---|---|
| MET+ICT+Conventional intervention | Experimental | Hot packs (75°C) for 20 minutes and supervised active stretching exercises for upper trapezius muscle (slow, 5 repetitions per session, 10-second hold and 10-second relaxation between two repetitions) followed by ICT (90-second hold-time) and MET (5-second hold-time, 3-second relaxation by exhalation while reaching the new barrier). Receives: Behavioral: MET; Behavioral: ICT; Behavioral: Conventional Intervention |
| MET+Conventional Intervention | Experimental | Hot packs (75°C) for 20 minutes and supervised active stretching exercises for upper trapezius muscle (slow, 5 repetitions per session, 10-second hold and 10-second relaxation between two repetitions) followed by MET (5-second hold-time, 3-second relaxation by exhalation while reaching the new barrier). Receives: Behavioral: MET; Behavioral: Conventional Intervention |
| Conventional Intervention | Active comparator | Received hot packs (75°C) for 20 minutes and supervised active stretching exercises for upper trapezius muscle (slow, 5 repetitions per session, 10-second hold and 10-second relaxation between two repetitions) only. Receives: Behavioral: Conventional Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle tenderness
A pressure algometer used to assess the muscle tenderness by measuring Pressure Pain Threshold (PPT) level of MTrPs as suggested by Fischer. The trigger point with the lowest PPT value was chosen as a primary trigger point. The subjects were instructed to indicate the sensation of pressure they felt from changing from one of pressure to one of pain by saying "there"/ "yes." Three repeated measurements were obtained by the same assistant, and the mean was used in the analysis. At least a 1-minute gap was added between the two repeated measurements as recommended by Fischer.
Measured: Change from baseline PPT scores at day 1 post intervention and after 2-weeks follow-up
Neck pain intensity
Visual analogue scale (VAS) used to measure neck pain intensity. VAS is a subjective rating scale marked with 0 (No pain) and 10 (extremely unbearable pain) on its either end. An application of 2.5 kg/cm-square of pressure was applied at the rate of 1 kg/cm-square by the physiotherapist while the subjects were stated to rate their pain on the visual analog scale (VAS) to evaluate local pain evoked by the application of that amount of pressure.
Measured: Change from baseline VAS scores at day 1 post intervention and after 2-weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start11 Aug 2017
- Primary completion19 Dec 2017
- Study completion15 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Trigger Point 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Collaborators
- Shah Physiotherapy Center, Delhi, India
- Responsible party
- Principal investigator, AMIR IQBAL, King Saud University
- Investigators
- Amir Iqbal, MPT, Principal investigator, Rehabilitation Research Chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03840473
- Sponsor's protocol ID
- RRC-2017-007
- Status last verified
- Feb 2019
- First submitted
- 11 Feb 2019
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Combination Therapies on Neck Pain and Muscle Tenderness in Patients With Upper Trapezius Myofascial Trigger Points
- ClinicalTrials.gov ID
- NCT03840473
- Acronym / sponsor ID
- RRC-2017-007
- Conditions
- Myofascial Trigger Point Pain
- Keywords
- Neck pain, Upper trapezius muscle, Myofascial trigger points, Muscle tenderness, Pain pressure threshold
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Collaborators
- Shah Physiotherapy Center, Delhi, India
- Study start
- 11 Aug 2017 (actual)
- Primary completion
- 19 Dec 2017 (actual)
- Study completion
- 15 Feb 2018 (actual)
- First posted
- 15 Feb 2019 (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.
Myofascial pain syndrome thought to be the main cause of neck pain and shoulder muscle tenderness in the working population is characterized by myofascial trigger points (MTrPs). This study aimed to examine the immediate and short-term effect of the combination of two therapeutic techniques for improving neck pain and muscle tenderness in patients with upper trapezius Myofascial Trigger points.
Detailed description
Purpose: Myofascial pain syndrome, thought to be the main cause of neck pain and shoulder muscle tenderness in the working population, is characterized by myofascial trigger points (MTrPs). This study aimed to examine the immediate and short-term effect of the combination of two therapeutic techniques for improving neck pain and muscle tenderness in male patients with upper trapezius active MTrPs.
Methods: This was a pretest-posttest single-blinded randomized controlled trial. Sixty male subjects with mechanical neck pain due to upper trapezius active MTrPs were recruited and randomly allocated into group A, which received muscle energy technique (MET) and ischemic compression technique (ICT)along with conventional intervention; group B, which received all the interventions of group A except ICT; and group C, which received conventional treatment only. Baseline (Pr), immediate post-intervention (Po), and 2-week follow-up (Fo) measurements were made for all variables. Pain intensity and pressure pain threshold (PPT)were assessed by a visual analog scale (VAS) and pressure threshold meter, respectively. All three groups received their defined intervention plans only. Repeated-measures analysis of variance was used to perform intra- inter-group analyses. Cohen's d test was used to assess the effect size of the applied interventions within the groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MET+ICT+Conventional intervention | Experimental | Behavioral: MET, Behavioral: ICT, Behavioral: Conventional InterventionHot packs (75°C) for 20 minutes and supervised active stretching exercises for upper trapezius muscle (slow, 5 repetitions per session, 10-second hold and 10-second relaxation between two repetitions) followed by ICT (90-second hold-time) and MET (5-second hold-time, 3-second relaxation by exhalation while reaching the new barrier). |
| MET+Conventional Intervention | Experimental | Behavioral: MET, Behavioral: Conventional InterventionHot packs (75°C) for 20 minutes and supervised active stretching exercises for upper trapezius muscle (slow, 5 repetitions per session, 10-second hold and 10-second relaxation between two repetitions) followed by MET (5-second hold-time, 3-second relaxation by exhalation while reaching the new barrier). |
| Conventional Intervention | Active comparator | Behavioral: Conventional InterventionReceived hot packs (75°C) for 20 minutes and supervised active stretching exercises for upper trapezius muscle (slow, 5 repetitions per session, 10-second hold and 10-second relaxation between two repetitions) only. |
Who may qualify
- Ages
- 19 to 38 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male subject diagnosed with non-specific neck pain and muscle tenderness over the upper trapezius muscle due to an active MTrP
- Age19-38 years
- Presence of a maximum of 1-2active MTrPs in a unilateral upper trapezius muscle The number of TrPs in upper trapezius is not limited to two; it may be one or may be more than two (satellite TrPs) also. However, due to time constraints of the study sessions allowed for treatment of up to 2 active MTrPs only.
Key exclusion criteria (6 listed)
- Diagnosed with fibromyalgia syndrome according to the American College of Rheumatology criteria;
- Had active MTrPs in the bilateral upper trapezius muscles
- Had a history of whiplash injury or cervical spine surgery
- Were diagnosed with cervical radiculopathy or myelopathy determined by their primary health care physician
- Had accepted myofascial pain therapy within the 1 month before 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 |
|---|---|---|
| METThe patient was in a supine position with the cervical spine in the opposite lateral flexion to the treating part so that the upper trapezius muscle fibers were in a lengthened position.19 The moderate isometric contraction (approximately 75% of maximal) of the upper trapezius muscles was elicited for a period of 5 seconds followed by 3 seconds of relaxation while reaching the new barrier. The technique was repeated four times in each session. | Behavioural | MET+Conventional Intervention, MET+ICT+Conventional intervention |
| ICTThe patient lying in the supine position with the cervical spine in opposite lateral flexion to the treating part so that the upper trapezius muscle fibers were kept in a lengthened position.18,22 The physiotherapist applied gradually increasing pressure to the MTrPs until the subject perceived the first noticeable pain. At that moment, the pressure was maintained until the discomfort and/or pain eased by around 50% as perceived by the patient, at which time the pressure was increased until the discomfort appeared again. This process was maintained for 90 seconds. | Behavioural | MET+ICT+Conventional intervention |
| Conventional InterventionHot packs (75°C) for 20 minutes and active stretching exercises for the upper trapezius muscle (slow, 5 repetitions per session, 10-second hold and 10-second relaxation between two repetitions). Active stretching exercises were done by all the participants under the supervision of the physical therapist. This approach was standardized for all participants. | Behavioural | Conventional Intervention, MET+Conventional Intervention, MET+ICT+Conventional intervention |
Primary outcome
Muscle tenderness
Time frame: Change from baseline PPT scores at day 1 post intervention and after 2-weeks follow-up
A pressure algometer used to assess the muscle tenderness by measuring Pressure Pain Threshold (PPT) level of MTrPs as suggested by Fischer. The trigger point with the lowest PPT value was chosen as a primary trigger point. The subjects were instructed to indicate the sensation of pressure they felt from changing from one of pressure to one of pain by saying "there"/ "yes." Three repeated measurements were obtained by the same assistant, and the mean was used in the analysis. At least a 1-minute gap was added between the two repeated measurements as recommended by Fischer.
Neck pain intensity
Time frame: Change from baseline VAS scores at day 1 post intervention and after 2-weeks follow-up
Visual analogue scale (VAS) used to measure neck pain intensity. VAS is a subjective rating scale marked with 0 (No pain) and 10 (extremely unbearable pain) on its either end. An application of 2.5 kg/cm-square of pressure was applied at the rate of 1 kg/cm-square by the physiotherapist while the subjects were stated to rate their pain on the visual analog scale (VAS) to evaluate local pain evoked by the application of that amount of pressure.
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 Feb 2019.
- Individual participant dataSharing planned: Undecided
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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 principal investigator
Rehabilitation Research Chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MET, ICT and Conventional Intervention in people with Myofascial Trigger Point 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 3 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 15 Feb 2019. 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?
Muscle tenderness (time frame: Change from baseline PPT scores at day 1 post intervention and after 2-weeks follow-up). 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 Feb 2019.