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

NCT ID: NCT04190784

Last Updated: 2020-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-05

Study Completion Date

2020-05-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Myofascial Pain Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A prospective, double blinded, parallel-group, randomized clinical trial was conducted at one of our university's research departments,
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

60 seconds stretching group

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.

Group Type EXPERIMENTAL

Stretching exercises

Intervention Type OTHER

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.

30 seconds stretching group

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

Group Type EXPERIMENTAL

Stretching exercises

Intervention Type OTHER

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.

15 seconds stretching group

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

Group Type EXPERIMENTAL

Stretching exercises

Intervention Type OTHER

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.

60 seconds placebo stretching group

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

Group Type PLACEBO_COMPARATOR

Placebo stretching

Intervention Type OTHER

The therapist maintains the same manual contact without stretching force.

30 seconds placebo stretching group

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

Group Type PLACEBO_COMPARATOR

Placebo stretching

Intervention Type OTHER

The therapist maintains the same manual contact without stretching force.

15 seconds placebo stretching group

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

Group Type PLACEBO_COMPARATOR

Placebo stretching

Intervention Type OTHER

The therapist maintains the same manual contact without stretching force.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Stretching exercises

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

Placebo stretching

The therapist maintains the same manual contact without stretching force.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Janda's post facilitation stretch method

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Sharjah

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ibrahim Moustafa

Associate professor-chair of Physiotherapy Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ibrahim M Moustafa, Assoc prof

Role: STUDY_DIRECTOR

University of Sharjah

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ibrahim Moustafa

Sharjah city, United Arab Emirate, United Arab Emirates

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Arab Emirates

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

University of Sharjah

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effectiveness of NMES on Neck Pain
NCT06320340 COMPLETED NA