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Optimal Duration of Stretching Exercises for Chronic Non-specific Neck Pain Patients

Primary Purpose

Myofascial Pain Syndrome

Status
Completed
Phase
Not Applicable
Locations
United Arab Emirates
Study Type
Interventional
Intervention
Stretching exercises
Placebo stretching
Sponsored by
University of Sharjah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myofascial Pain Syndrome focused on measuring Randomized controlled trial, Myofascial Pain Syndrome, Stretching exercises, nerve root function

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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:

  1. Regional pain complaint in the neck.
  2. Pain complaint or altered sensation in the expected distribution of referred pain from a myofascial trigger point.
  3. Taut band palpable in an accessible muscle.
  4. Excruciating spot tenderness at one point along the length of the taut band.
  5. Some degree of restricted range of motion , when measurable.

Minor criteria:

  1. Reproduction of clinical pain complaint, or altered sensation, by pressure on the tender spot.
  2. 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.
  3. Pain alleviated by elongating (stretching) the muscle or by injecting the tender spot (trigger point).

Exclusion Criteria:

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.

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Sites / Locations

  • Ibrahim Moustafa

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Placebo Comparator

Arm Label

60 seconds stretching group

30 seconds stretching group

15 seconds stretching group

60 seconds placebo stretching group

30 seconds placebo stretching group

15 seconds placebo stretching group

Arm Description

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.

The same procedures while the therapist will maintain the stretch for 30 seconds.

The same procedures while the therapist will maintain the stretch for 15 seconds.

The therapist will maintain the same manual contact without stretching force for 60 seconds

The therapist will maintain the same manual contact without stretching force for 30 seconds

The therapist will maintain the same manual contact without stretching force for 15 seconds

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
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''.
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.

Full Information

First Posted
December 3, 2019
Last Updated
May 13, 2020
Sponsor
University of Sharjah
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1. Study Identification

Unique Protocol Identification Number
NCT04190784
Brief Title
Optimal Duration of Stretching Exercises for Chronic Non-specific Neck Pain Patients
Official Title
Optimal Duration of Stretching Exercises for Chronic Non-specific Neck Pain Patients:Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
May 5, 2020 (Actual)
Primary Completion Date
May 14, 2020 (Actual)
Study Completion Date
May 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sharjah

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain Syndrome
Keywords
Randomized controlled trial, Myofascial Pain Syndrome, Stretching exercises, nerve root function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A prospective, double blinded, parallel-group, randomized clinical trial was conducted at one of our university's research departments,
Masking
ParticipantInvestigator
Masking Description
The treating therapist, for both the control and intervention groups, was unblinded to the treatment method but the subjects and assessor who conducted the measurements were blinded. Assessor blinding was obtained through an independent research assist; not knowing the study design and not specifically involved in any aspect of the trial
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
60 seconds stretching group
Arm Type
Experimental
Arm Description
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.
Arm Title
30 seconds stretching group
Arm Type
Experimental
Arm Description
The same procedures while the therapist will maintain the stretch for 30 seconds.
Arm Title
15 seconds stretching group
Arm Type
Experimental
Arm Description
The same procedures while the therapist will maintain the stretch for 15 seconds.
Arm Title
60 seconds placebo stretching group
Arm Type
Placebo Comparator
Arm Description
The therapist will maintain the same manual contact without stretching force for 60 seconds
Arm Title
30 seconds placebo stretching group
Arm Type
Placebo Comparator
Arm Description
The therapist will maintain the same manual contact without stretching force for 30 seconds
Arm Title
15 seconds placebo stretching group
Arm Type
Placebo Comparator
Arm Description
The therapist will maintain the same manual contact without stretching force for 15 seconds
Intervention Type
Other
Intervention Name(s)
Stretching exercises
Other Intervention Name(s)
Janda's post facilitation stretch method
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo stretching
Intervention Description
The therapist maintains the same manual contact without stretching force.
Primary Outcome Measure Information:
Title
The change in peak-to-peak amplitudes of dermatomal somatosensory evoked potentials for C4,C5,C6,C7,&C8
Description
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
Time Frame
will be measured at two intervals ;pre-treatment and immediately after treatment
Secondary Outcome Measure Information:
Title
The change in central conduction time
Description
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.
Time Frame
will be measured at two intervals ;pre-treatment and immediately after treatment.
Title
The change in Neck Disability Index
Description
The Neck Disability Index , consisting of 10 items related to daily living activities, will be our primary patient-reported outcome measure.
Time Frame
will be measured at two intervals ;pre-treatment and immediately after treatment.
Title
The change in Cervical range of motion
Description
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.
Time Frame
will be measured at two intervals ;pre-treatment and immediately after treatment
Title
The change in Neck pain intensity
Description
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''.
Time Frame
will be measured at two intervals ;pre-treatment and immediately after treatment
Title
The change in Pressure-pain threshold , algometric measurement
Description
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.
Time Frame
will be measured at two intervals ;pre-treatment and immediately after treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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). Exclusion Criteria: 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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ibrahim M Moustafa, Assoc prof
Organizational Affiliation
University of Sharjah
Official's Role
Study Director
Facility Information:
Facility Name
Ibrahim Moustafa
City
Sharjah
State/Province
United Arab Emirate
ZIP/Postal Code
27272
Country
United Arab Emirates

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
There is a plan to make individual participant data and related data dictionaries available
IPD Sharing Time Frame
After 6 months and will become available for one year
IPD Sharing Access Criteria
not identified yet
Citations:
Citation
Backes WH, Nijenhuis RJ (2008): Advances in spinal cord MR angiography. AJNR Am J Neuroradiol ; 29(4):619-31. Biglioli, Paolo; et alia (2004): Upper and lower spinal cord blood supply: the continuity of the anterior spinal artery and the relevance of the lumbar arteries. Journal of Thoracic and Cardiovascular Surgery 127 (4): 1188-1192. Challis, J.H. (1995): A procedure for determining rigid body transformation parameters. J Biomech 28, 733-737. Cheung, Karoline, Patria A. Hume, and Linda Maxwell. (2003): Delayed Onset Muscle Soreness: Treatment Strategies and Performance Factors.
Results Reference
background

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Optimal Duration of Stretching Exercises for Chronic Non-specific Neck Pain Patients

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