- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04484324
Optimal Duration of Stretching Exercise in Patients With Chronic Mechanical Neck Pain
Optimal Duration of Stretching Exercise in Patients With Chronic Mechanical Neck Pain: A Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Sharjah, United Arab Emirates, 27272
- University of Sharjah
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United Arab Emirate
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Sharjah, United Arab Emirate, United Arab Emirates, 27272
- Ibrahim Moustafa
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Subjects' exclusion criteria included specific neck pain due to trauma, disc protrusion, whiplash, congenital deformity of the spine, spinal stenosis, neoplasm, inflammatory or rheumatic disease. Furthermore, subjects were excluded if they had a history of spine surgery and any objective findings consistent with neurological conditions and vascular disorders.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 60 seconds
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.
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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.
Other Names:
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Experimental: 30 seconds
The same procedures while the therapist will maintain the stretch for 30 seconds.
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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.
Other Names:
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Experimental: 15 seconds
The same procedures while the therapist will maintain the stretch for 15 seconds.
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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.
Other Names:
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Placebo Comparator: control
The therapist maintains the same manual contact without stretching force
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The change in peak-to-peak amplitudes of dermatomal somatosensory evoked potentials
Time Frame: will be measured at two intervals ;pre-treatment and 24 Hours after treatment
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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
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will be measured at two intervals ;pre-treatment and 24 Hours after treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The change in Neck Disability Index
Time Frame: will be measured at two intervals ;pre-treatment and 24 Hours after treatment
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The Neck Disability Index , consisting of 10 items related to daily living activities, will be our primary patient-reported outcome measure.
Each item is scored out of five (with the no disability response given a score of 0) giving a total score for the questionnaire out of 50.
Higher scores represent greater disability.
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will be measured at two intervals ;pre-treatment and 24 Hours after treatment
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The change in Cervical range of motion
Time Frame: will be measured at two intervals ;pre-treatment and 24 Hours after treatment
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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.
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will be measured at two intervals ;pre-treatment and 24 Hours after treatment
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The change in Neck pain intensity
Time Frame: will be measured at two intervals ;pre-treatment and 24 Hours after treatment
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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''.
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will be measured at two intervals ;pre-treatment and 24 Hours after treatment
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ibrahim Moustafa, University of Sharjah
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- USharjah2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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