Myofascial Pain SyndromeNCT04190784
Optimal Duration of Stretching Exercises for Chronic Non-specific Neck Pain Patients
A study testing Stretching exercises in people with Myofascial Pain Syndrome, run by University of Sharjah at 1 site in United Arab Emirates.
Trial summary
A multitude of stretching parameters are used in the clinical setting. However, there is no convincing evidence to suggest which parameters are most effective in the management of chronic myofascial pain syndrome .In this regard, although the stretching duration is considered one of the most important variables that… Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Myofascial Pain Syndrome
- What is being tested?
- Stretching exercises
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 5 May 2020to 14 May 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 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Consecutive patients will be included if they have active, palpable Myofascial trigger points on a single side or both sides of the upper trapezius muscle. Diagnosis was made according to Simons criteria, which includes five major and three minor criteria. For inclusion, cervical myofascial pain syndrome will be diagnosed with all five major criteria and at least one minor criterion.
- Major criteria:
- Regional pain complaint in the neck.
- Pain complaint or altered sensation in the expected distribution of referred pain from a myofascial trigger point.
- Taut band palpable in an accessible muscle.
- Excruciating spot tenderness at one point along the length of the taut band.
Show all 11Show fewer
- Some degree of restricted range of motion , when measurable.
- Minor criteria:
- Reproduction of clinical pain complaint, or altered sensation, by pressure on the tender spot.
- Elicitation of a local twitch response by transverse snapping palpation at the tender spot or by needle insertion into the tender spot in the taut band.
- Pain alleviated by elongating (stretching) the muscle or by injecting the tender spot (trigger point).
Who cannot join
- Participants will be excluded if any signs or symptoms of medical "red flags" were present: tumor, fracture, rheumatoid arthritis, osteoporosis, and prolonged steroid use. Additionally, subjects will be excluded with previous spine surgery and any exam findings consistent with neurological diseases and vascular disorders.
- -
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
Ibrahim Moustafa
Sharjah city, United Arab Emirate, 27272
About this study
Official title: Optimal Duration of Stretching Exercises for Chronic Non-specific Neck Pain Patients:Randomized Controlled Trial
A multitude of stretching parameters are used in the clinical setting. However, there is no convincing evidence to suggest which parameters are most effective in the management of chronic myofascial pain syndrome .In this regard, although the stretching duration is considered one of the most important variables that can affect the treatment outcome, to date there is little agreement on the most effective stretching duration.Accordingly ,we will conduct this study to investigate the effect of different stretching duration on nerve root function ,central conduction time, and chronic myofascial pain management outcomes.
Read the detailed description
As Upper trapezius and levator scapulae are the most common postural muscles that tends to get shorten leading to restricted neck mobility as they are most frequently used to maintain posture,there seems to be strong rationale for stretching these muscles however, to date there is no agreement about the optimal stretching parameters . A multitude of stretching parameters are used in the clinical setting. However, there is no convincing evidence to suggest which parameters are most effective in the management of Chronic myofascial pain syndrome . In this regard, although the stretching duration is considered one of the most important variables that can affect the treatment outcome, to date there is little agreement on the most effective stretching duration.
In theory, reflex inhibition during the stretching procedure, an increased stretch tolerance , decreased viscoelasticity, and a degree of reduced musculotendinous stiffness could all contribute to the sustained increase in elastic ROM. Regardless of these proven underlying mechanisms, all the previous studies ignored the adverse mechanical tension that developed during stretching exercises . Based on the literature, this tension may adversely affect the central nervous system and nerve root function . Accordingly, in the current study ,we will try to answer the question that is it theoretically possible, that increased longitudinal stress and strain on the spinal cord and nerve root from stretching exercises may subtly impair the neural function.in addition to investigate the effect of stretching on other management outcomes;pain intensity,disability,range of motion,and Pressure-pain threshold.
- Conditions
- Myofascial Pain Syndrome
- Being tested
- Stretching exercises, Placebo stretching
- Keywords
- Randomized controlled trial, Myofascial Pain Syndrome, Stretching exercises, nerve root function
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stretching exercisesOther
Also called Janda's post facilitation stretch method
Post-facilitation stretch is a technique involves a maximal contraction of the muscle at mid-range with a rapid movement to maximal length followed by a static stretch.
Placebo stretchingOther
The therapist maintains the same manual contact without stretching force.
| Study group | Role | What they receive |
|---|---|---|
| 60 seconds stretching group | Experimental | Stretching exercises for upper Trapezius and Levator scapula .
From supine position , the examiner will passively place the participant's head into flexion, side-bending away and rotation towards the side to be stretched (for upper trapezius muscle) and flexion, side-bending away and rotation away from the side to be stretched (for levator scapula ). The patient introduces a light resisted effort to take the stabilized shoulder towards the ear and the ear towards the shoulder. The contraction is sustained for 10 seconds and, upon complete relaxation of effort, the therapist gently eases the head/ neck into an increased degree of side-bending and rotation, where it is stabilized, as the shoulder is stretched caudally. The examiner will depress the participant's shoulder with 100 Newton's of force measured with pressure dynamometer. Once the examiner achieved this level of force, he maintains the stretch for 60 seconds . The procedure is repeated three times. Receives: Other: Stretching exercises |
| 30 seconds stretching group | Experimental | The same procedures while the therapist will maintain the stretch for 30 seconds. Receives: Other: Stretching exercises |
| 15 seconds stretching group | Experimental | The same procedures while the therapist will maintain the stretch for 15 seconds. Receives: Other: Stretching exercises |
| 60 seconds placebo stretching group | Placebo comparator | The therapist will maintain the same manual contact without stretching force for 60 seconds Receives: Other: Placebo stretching |
| 30 seconds placebo stretching group | Placebo comparator | The therapist will maintain the same manual contact without stretching force for 30 seconds Receives: Other: Placebo stretching |
| 15 seconds placebo stretching group | Placebo comparator | The therapist will maintain the same manual contact without stretching force for 15 seconds Receives: Other: Placebo stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in peak-to-peak amplitudes of dermatomal somatosensory evoked potentials for C4,C5,C6,C7,&C8
Dermatomal Somatosensory Evoked Potentials will be elicited by repetitive, square wave (0.5 ms) electrical pulses (at 3 Hz) from standard clinical surface gel electrodes (20 mm) overlying cervical sensory dermatomes. Dermatomal somatosensory evoked potential will be collected at a stimulus intensity well above perception threshold.Complete recording runs will be undertaken during each session with averages of 250 to 1200 cortical responses from scalp surface recording electrodes (C3'-C4' in a 10-20 electrode configuration) of the contralateral scalp to the C4 to C8 dermatomes being stimulated
Measured: will be measured at two intervals ;pre-treatment and immediately after treatment
Secondary outcomes (5)
The change in central conduction time
For central somatosensory conduction time measurement, N13-N20 will be determined for each subject following standard clinical procedure for upper limb stimulation (median nerve at the wrist). The difference in peak latency between N13 and N20 will be measured as central conduction time.
Measured: will be measured at two intervals ;pre-treatment and immediately after treatment.
The change in Neck Disability Index
The Neck Disability Index , consisting of 10 items related to daily living activities, will be our primary patient-reported outcome measure.
Measured: will be measured at two intervals ;pre-treatment and immediately after treatment.
The change in Cervical range of motion
Cervical spine global range-of-motion will be measured using the valid and reliable cervical range-of-motion (CROM) device. The participant will perform flexion, extension, right/left lateral flexion, right/left rotation in upright sitting. The patient was instructed to perform each movement when he/she attained the maximum active range of motion. Three trials were conducted for each direction of movement, and the average of the three measurements will be recorded for analysis.
Measured: will be measured at two intervals ;pre-treatment and immediately after treatment
The change in Neck pain intensity
Neck pain intensity will be measured using the numerical pain rating scale . The patients will be asked to place a mark along the line indicating their current pain intensity; 0 reflecting ''no pain'' and 10 reflecting the ''worst pain''.
Measured: will be measured at two intervals ;pre-treatment and immediately after treatment
The change in Pressure-pain threshold , algometric measurement
A pressure threshold algometer will be used to measure pressure-pain threshold in the most tender point of the upper trapezius and levator muscles. The average value of 3 repetitive measurements with an interval of 30 to 60 seconds will be taken for data analysis.
Measured: will be measured at two intervals ;pre-treatment and immediately after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start5 May 2020
- Primary completion14 May 2020
- Study completion14 May 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 Myofascial Pain SyndromeStudies 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
- A prospective, double blinded, parallel-group, randomized clinical trial was conducted at one of our university's research departments,
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sharjah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Moustafa, University of Sharjah
- Investigators
- Ibrahim M Moustafa, Assoc prof, Study director, University of Sharjah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04190784
- Sponsor's protocol ID
- University of Sharjah
- Status last verified
- May 2020
- First submitted
- 3 Dec 2019
- Last updated
- 15 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is a plan to make individual participant data and related data dictionaries available
Publications
Biglioli P, Roberto M, Cannata A, Parolari A, Fumero A, Grillo F, Maggioni M, Coggi G, Spirito R. Upper and lower spinal cord blood supply: the continuity of the anterior spinal artery and the relevance of the lumbar arteries. J Thorac Cardiovasc Surg. 2004 Apr;127(4):1188-92. doi: 10.1016/j.jtcvs.2003.11.038.
PubMed 15052221
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Duration of Stretching Exercises for Chronic Non-specific Neck Pain Patients:Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04190784
- Acronym / sponsor ID
- University of Sharjah
- Conditions
- Myofascial Pain Syndrome
- Keywords
- Randomized controlled trial, Myofascial Pain Syndrome, Stretching exercises, nerve root function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- University of SharjahUniversity, hospital or other
- Study start
- 5 May 2020 (actual)
- Primary completion
- 14 May 2020 (actual)
- Study completion
- 14 May 2020 (actual)
- First posted
- 9 Dec 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.
A multitude of stretching parameters are used in the clinical setting. However, there is no convincing evidence to suggest which parameters are most effective in the management of chronic myofascial pain syndrome .In this regard, although the stretching duration is considered one of the most important variables that can affect the treatment outcome, to date there is little agreement on the most effective stretching duration.Accordingly ,we will conduct this study to investigate the effect of different stretching duration on nerve root function ,central conduction time, and chronic myofascial pain management outcomes.
Detailed description
As Upper trapezius and levator scapulae are the most common postural muscles that tends to get shorten leading to restricted neck mobility as they are most frequently used to maintain posture,there seems to be strong rationale for stretching these muscles however, to date there is no agreement about the optimal stretching parameters . A multitude of stretching parameters are used in the clinical setting. However, there is no convincing evidence to suggest which parameters are most effective in the management of Chronic myofascial pain syndrome . In this regard, although the stretching duration is considered one of the most important variables that can affect the treatment outcome, to date there is little agreement on the most effective stretching duration.
In theory, reflex inhibition during the stretching procedure, an increased stretch tolerance , decreased viscoelasticity, and a degree of reduced musculotendinous stiffness could all contribute to the sustained increase in elastic ROM. Regardless of these proven underlying mechanisms, all the previous studies ignored the adverse mechanical tension that developed during stretching exercises . Based on the literature, this tension may adversely affect the central nervous system and nerve root function . Accordingly, in the current study ,we will try to answer the question that is it theoretically possible, that increased longitudinal stress and strain on the spinal cord and nerve root from stretching exercises may subtly impair the neural function.in addition to investigate the effect of stretching on other management outcomes;pain intensity,disability,range of motion,and Pressure-pain threshold.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
- Model description
- A prospective, double blinded, parallel-group, randomized clinical trial was conducted at one of our university's research departments,
| Arm | Type | Receives |
|---|---|---|
| 60 seconds stretching group | Experimental | Other: Stretching exercisesStretching exercises for upper Trapezius and Levator scapula . From supine position , the examiner will passively place the participant's head into flexion, side-bending away and rotation towards the side to be stretched (for upper trapezius muscle) and flexion, side-bending away and rotation away from the side to be stretched (for levator scapula ). The patient introduces a light resisted effort to take the stabilized shoulder towards the ear and the ear towards the shoulder. The contraction is sustained for 10 seconds and, upon complete relaxation of effort, the therapist gently eases the head/ neck into an increased degree of side-bending and rotation, where it is stabilized, as the shoulder is stretched caudally. The examiner will depress the participant's shoulder with 100 Newton's of force measured with pressure dynamometer. Once the examiner achieved this level of force, he maintains the stretch for 60 seconds . The procedure is repeated three times. |
| 30 seconds stretching group | Experimental | Other: Stretching exercisesThe same procedures while the therapist will maintain the stretch for 30 seconds. |
| 15 seconds stretching group | Experimental | Other: Stretching exercisesThe same procedures while the therapist will maintain the stretch for 15 seconds. |
| 60 seconds placebo stretching group | Placebo comparator | Other: Placebo stretchingThe therapist will maintain the same manual contact without stretching force for 60 seconds |
| 30 seconds placebo stretching group | Placebo comparator | Other: Placebo stretchingThe therapist will maintain the same manual contact without stretching force for 30 seconds |
| 15 seconds placebo stretching group | Placebo comparator | Other: Placebo stretchingThe therapist will maintain the same manual contact without stretching force for 15 seconds |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Consecutive patients will be included if they have active, palpable Myofascial trigger points on a single side or both sides of the upper trapezius muscle. Diagnosis was made according to Simons criteria, which includes five major and three minor criteria. For inclusion, cervical myofascial pain syndrome will be diagnosed with all five major criteria and at least one minor criterion.
- Regional pain complaint in the neck.
- Pain complaint or altered sensation in the expected distribution of referred pain from a myofascial trigger point.
- Taut band palpable in an accessible muscle.
- Excruciating spot tenderness at one point along the length of the taut band.
Key exclusion criteria (2 listed)
- Participants will be excluded if any signs or symptoms of medical "red flags" were present: tumor, fracture, rheumatoid arthritis, osteoporosis, and prolonged steroid use. Additionally, subjects will be excluded with previous spine surgery and any exam findings consistent with neurological diseases and vascular disorders.
- -
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 |
|---|---|---|
| Stretching exercisesAlso: Janda's post facilitation stretch methodPost-facilitation stretch is a technique involves a maximal contraction of the muscle at mid-range with a rapid movement to maximal length followed by a static stretch. | Other | 15 seconds stretching group, 30 seconds stretching group, 60 seconds stretching group |
| Placebo stretchingThe therapist maintains the same manual contact without stretching force. | Other | 15 seconds placebo stretching group, 30 seconds placebo stretching group, 60 seconds placebo stretching group |
Primary outcome
The change in peak-to-peak amplitudes of dermatomal somatosensory evoked potentials for C4,C5,C6,C7,&C8
Time frame: will be measured at two intervals ;pre-treatment and immediately after treatment
Dermatomal Somatosensory Evoked Potentials will be elicited by repetitive, square wave (0.5 ms) electrical pulses (at 3 Hz) from standard clinical surface gel electrodes (20 mm) overlying cervical sensory dermatomes. Dermatomal somatosensory evoked potential will be collected at a stimulus intensity well above perception threshold.Complete recording runs will be undertaken during each session with averages of 250 to 1200 cortical responses from scalp surface recording electrodes (C3'-C4' in a 10-20 electrode configuration) of the contralateral scalp to the C4 to C8 dermatomes being stimulated
5 secondary outcomes
The change in central conduction time
Time frame: will be measured at two intervals ;pre-treatment and immediately after treatment.
The change in Neck Disability Index
Time frame: will be measured at two intervals ;pre-treatment and immediately after treatment.
The change in Cervical range of motion
Time frame: will be measured at two intervals ;pre-treatment and immediately after treatment
The change in Neck pain intensity
Time frame: will be measured at two intervals ;pre-treatment and immediately after treatment
The change in Pressure-pain threshold , algometric measurement
Time frame: will be measured at two intervals ;pre-treatment and immediately after treatment.
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 May 2020.
- Background: PubMed 15052221Biglioli P, Roberto M, Cannata A, Parolari A, Fumero A, Grillo F, Maggioni M, Coggi G, Spirito R. Upper and lower spinal cord blood supply: the continuity of the anterior spinal artery and the relevance of the lumbar arteries. J Thorac Cardiovasc Surg. 2004 Apr;127(4):1188-92. doi: 10.1016/j.jtcvs.2003.11.038.
- Individual participant dataSharing planned: Yes. There is a plan to make individual participant data and related data dictionaries available
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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.
Ibrahim M Moustafa, Assoc prof study director
University of Sharjah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stretching exercises in people with Myofascial Pain Syndrome, run by University of Sharjah at 1 site in United Arab Emirates.
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 11 inclusion and 2 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 May 2020. 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 United Arab Emirates. 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. Some participants in this study may receive a placebo. 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?
The change in peak-to-peak amplitudes of dermatomal somatosensory evoked potentials for C4,C5,C6,C7,&C8 (time frame: will be measured at two intervals ;pre-treatment and immediately after treatment). 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 NCT04190784, 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 15 May 2020.