Clinical trial NCT04190784: 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
Overall status: COMPLETED
Phase: NA
Conditions: Myofascial Pain Syndrome
Keywords: Randomized controlled trial
Myofascial Pain Syndrome
Stretching exercises
nerve root function
Lead sponsor: University of Sharjah
Sponsor class: OTHER
First posted: 2019-12-09
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, double blinded, parallel-group, randomized clinical trial was conducted at one of our university's research departments,
Primary purpose: TREATMENT

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.

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:

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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Primary outcomes:
measure: The change in peak-to-peak amplitudes of dermatomal somatosensory evoked potentials for C4,C5,C6,C7,&C8
timeFrame: will be measured at two intervals ;pre-treatment and immediately after treatment
Secondary outcomes:
measure: The change in central conduction time
timeFrame: will be measured at two intervals ;pre-treatment and immediately after treatment.
measure: The change in Neck Disability Index
timeFrame: will be measured at two intervals ;pre-treatment and immediately after treatment.
measure: The change in Cervical range of motion
timeFrame: will be measured at two intervals ;pre-treatment and immediately after treatment
measure: The change in Neck pain intensity
timeFrame: will be measured at two intervals ;pre-treatment and immediately after treatment
measure: The change in Pressure-pain threshold , algometric measurement
timeFrame: will be measured at two intervals ;pre-treatment and immediately after treatment.
Other outcomes:
Locations:
city: Sharjah
country: United Arab Emirates
facility: Ibrahim Moustafa
state: United Arab Emirate
Study officials:
affiliation: University of Sharjah
name: Ibrahim M Moustafa, Assoc prof
role: STUDY_DIRECTOR
References:
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.