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

NCT04190784 | Completed DMC

• 1 other identifier: University of Sharjah
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Myofascial Pain Syndrome

Keywords

Randomized controlled trial; Myofascial Pain Syndrome; Stretching exercises; nerve root function

Outcome Measures

Primary Outcomes (1)

• 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

  will be measured at two intervals ;pre-treatment and immediately after treatment

Secondary Outcomes (5)

• The change in central conduction time

  will be measured at two intervals ;pre-treatment and immediately after treatment.

• The change in Neck Disability Index

  will be measured at two intervals ;pre-treatment and immediately after treatment.

• The change in Cervical range of motion

  will be measured at two intervals ;pre-treatment and immediately after treatment

• The change in Neck pain intensity

  will be measured at two intervals ;pre-treatment and immediately after treatment

• The change in Pressure-pain threshold , algometric measurement

  will be measured at two intervals ;pre-treatment and immediately after treatment.

Study Arms (6)

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.

Other: Stretching exercises

30 seconds stretching group

EXPERIMENTAL

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

Other: Stretching exercises

15 seconds stretching group

EXPERIMENTAL

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

Other: Stretching exercises

60 seconds placebo stretching group

PLACEBO COMPARATOR

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

Other: Placebo stretching

30 seconds placebo stretching group

PLACEBO COMPARATOR

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

Other: Placebo stretching

15 seconds placebo stretching group

PLACEBO COMPARATOR

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

Other: Placebo stretching

Interventions

Stretching exercises 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.

Also known as: Janda's post facilitation stretch method

15 seconds stretching group; 30 seconds stretching group; 60 seconds stretching group

Placebo stretching OTHER

The therapist maintains the same manual contact without stretching force.

15 seconds placebo stretching group; 30 seconds placebo stretching group; 60 seconds placebo stretching group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sharjah: lead

Study Sites (1)

Ibrahim Moustafa

Sharjah city, United Arab Emirate, 27272, United Arab Emirates

Location

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ibrahim M Moustafa, Assoc prof

  University of Sharjah

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor-chair of Physiotherapy Department

Model Details: A prospective, double blinded, parallel-group, randomized clinical trial was conducted at one of our university's research departments,

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 9, 2019
• Study Start: May 5, 2020
• Primary Completion: May 14, 2020
• Study Completion: May 14, 2020
• Last Updated: May 15, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After 6 months and will become available for one year
• Access Criteria: not identified yet

Locations

AE (1)