NCT04484324

Brief Summary

controversy remains about the stretching parameters needed to achieve a particular goal or treatment outcome. In clinical practice, multiple stretching techniques are used; nevertheless, there is no evidence-based agreement on the most effective parameters. One of these parameters, that might be affecting the treatment outcome the most, is the stretching duration, thus far there is a little agreement on the optimal stretching duration. This non agreement in exact stretching parameters is obvious between authors and researchers in the field of muscle energy techniques (MET) as well as those who have used and advocate various durations for the passive stretch that follows the contraction phase in MET.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 5, 2020

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 11, 2020

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 23, 2020

Completed
Last Updated

December 30, 2020

Status Verified

December 1, 2020

Enrollment Period

6 days

First QC Date

July 20, 2020

Last Update Submit

December 29, 2020

Conditions

Keywords

Randomized controlled trialmuscle energy techniqueStretching exercises

Outcome Measures

Primary Outcomes (1)

  • The change in peak-to-peak amplitudes of dermatomal somatosensory evoked potentials

    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 24 Hours after treatment

Secondary Outcomes (3)

  • The change in Neck Disability Index

    will be measured at two intervals ;pre-treatment and 24 Hours after treatment

  • The change in Cervical range of motion

    will be measured at two intervals ;pre-treatment and 24 Hours after treatment

  • The change in Neck pain intensity

    will be measured at two intervals ;pre-treatment and 24 Hours after treatment

Study Arms (4)

60 seconds

EXPERIMENTAL

60 seconds stretching group Stretching exercises for upper Trapezius and Levator 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

EXPERIMENTAL

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

Other: Stretching exercises

15 seconds

EXPERIMENTAL

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

Other: Stretching exercises

control

PLACEBO COMPARATOR

The therapist maintains the same manual contact without stretching force

Other: Stretching exercises

Interventions

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: muscle energy technique
15 seconds30 seconds60 secondscontrol

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Eligible patients had to be between 18 and 40 years of age
  • have generalized neck pain for more than 3 months.
  • with symptoms provoked by neck postures, movements, or palpation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ibrahim Moustafa

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

Location

University of Sharjah

Sharjah city, 27272, United Arab Emirates

Location

Related Publications (1)

  • Allison, T, G McCarthy, C C Wood, and S J Jones. 1991. "Potentials Evoked in Human and Monkey Cerebral Cortex by Stimulation of the Median Nerve. A Review of Scalp and Intracranial Recordings." Brain : A Journal of Neurology, December, 2465-2503. Baker, P F, M Ladds, and K A Rubinson. 1977. "Measurement of the Flow Properties of Isolated Axoplasm in a Defined Chemical Environment [Proceedings]." The Journal of Physiology 269 (1): 10P-11P. http://www.ncbi.nlm.nih.gov/pubmed/70528. Bandy, William D, and Jean M Irion. 1994. "The Effect of Time on Static Stretch on the Flexibility of the Hamstring Muscles." Physical Therapy 74 (9): 845-50. https://doi.org/10.1093/ptj/74.9.845. Bandy, William D, Jean M Irion, and Michelle Briggler. 1997. "The Effect of Time and Frequency of Static Stretching on Flexibility of the Hamstring Muscles." Physical Therapy 77 (10): 1090-96. https://doi.org/10.1093/ptj/77.10.1090. Bijur, Polly E, Clarke T Latimer, and E John Gallagher. 2003. "Validation of a Verbally Administered Numerical Rating Scale of Acute Pain for Use in the Emergency Department." Academic Emergency Medicine : Official Journal of the Society for Academic Emergency Medicine 10 (4): 390-92. http://www.ncbi.nlm.nih.gov/pubmed/12670856. Breig, Alf. 1978. Adverse Mechanical Tension in the Central Nervous System: An Analysis of Cause and Effect: Relief by Functional Neurosurgery. Almqvist & Wiksell International. Chaitow, Leon., Helge. Franke, and Leon. Chaitow. 2013. Muscle Energy Techniques. Churchill Livingstone/Elsevier. Cox, James M. 2000. "A Review of Biomechanics of the Central Nervous System. Part I: Spinal Canal Deformations Caused by Changes in Posture (Multiple Letters)." Journal of Manipulative and Physiological Therapeutics. https://doi.org/10.1016/s0161-4754(00)90252-5. Cunha, ACV, TN Burke, FJR França, AP Marques - Clinics, and undefined 2008. n.d. "Effect of Global Posture Reeducation and of Static Stretching on Pain, Range of Motion, and Quality of Life in Women with Chronic Neck Pain: A Randomized Clinical." SciELO Brasil. Accessed July 21, 2020. https://www.scielo.br/scielo.php?pid=S1807-59322008000600010&script=sci_arttext&tlng=pt. "Effectiveness of a Home Program of Ischemic Pressure Followed by Sustained Stretch for Treatment of Myofascial Trigger Points." 2016. Physical Therapy, November. https://doi.org/10.1093/ptj/80.10.997. Fejer, René, Kirsten Ohm Kyvik, and Jan Hartvigsen. 2006. "The Prevalence of Neck Pain in the World Population: A Systematic Critical Review of the Literature." European Spine Journal. Springer. https://doi.org/10.1007/s00586-004-0864-4. Fernández-de-las-Peñas, César, Luis Palomeque-del-Cerro, Cleofás Rodríguez-Blanco, Antonia Gómez-Conesa, and Juan C. Miangolarra-Page. 2007. "Changes in Neck Pain and Active Range of Motion After a Single Thoracic Spine Manipulation in Subjects Presenting with Mechanical Neck Pain: A Case Series." Journal of Manipulative and Physiological Therapeutics 30 (4): 312-20. https://doi.org/10.1016/j.jmpt.2007.03.007. Grosso MJ, Hwang R, Mroz T, Benzel E, Steinmetz M P. 2013. "Relationship between Degree of Focal Kyphosis Correction and Neurological Outcomes for Patients Undergoing Cervical Deformity Correction Surgery." J Neurosurg Spine. 18 (6): 537-44. Harrison, D D E, R Cailliet, D D E Harrison, S J Troyanovich, and S O Harrison. 1999. "A Review of Biomechanics of the Central Nervous System--Part II: Spinal Cord Strains from Postural Loads." Journal of Manipulative and Physiological Therapeutics 22 (5): 322-32. http://www.ncbi.nlm.nih.gov/pubmed/10395435. Harrison, D E, R Cailliet, D D Harrison, S J Troyanovich, and S O Harrison. n.d. "A Review of Biomechanics of the Central Nervous System--Part III: Spinal Cord Stresses from Postural Loads and Their Neurologic Effects." Journal of Manipulative and Physiological Therapeutics 22 (6): 399-410. http://www.ncbi.nlm.nih.gov/pubmed/10478773. Jeffery Brent Feland Joseph William Myrer, +2 authors G W Measom. 2001. "The Effect of Duration of Stretching of the Hamstring Muscle Group for Increasing Range of Motion in People Aged 65 Years or Older." Physical Therapy, May. https://doi.org/10.1093/ptj/81.5.1110.

    RESULT

MeSH Terms

Interventions

Muscle Stretching Exercises

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ibrahim Moustafa

    University of Sharjah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
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 tria
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A prospective, double blinded, parallel-group, randomized clinical trial was conducted at one of our university's research departments,
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor-chair of Physiotherapy Department Affiliation: University of Sharjah

Study Record Dates

First Submitted

July 20, 2020

First Posted

July 23, 2020

Study Start

July 5, 2020

Primary Completion

July 11, 2020

Study Completion

July 20, 2020

Last Updated

December 30, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will share

There is a plan to make individual participant data and related data dictionaries available

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
After 6 months and will become available for one year
Access Criteria
not identified yet

Locations