Optimal Duration of Stretching of the Hamstring Muscle Group

Physical and Rehabilitation Medicine Clinical Trial

Official title:

Optimal Duration of Stretching of the Hamstring Muscle Group : A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04441801
• Other study ID #: USharjah
• Status: Completed
• Phase: N/A
• Start date: June 5, 2020
• Est. completion date: September 20, 2020

Study information

• Verified date: October 2020
• Source: University of Sharjah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

OBJECTIVE: To explore the effect of variable stretching intervals on neural function and ROM. DESIGN: Randomized controlled trial Participants: In this trial, 168 participants diagnosed with tight hamstring muscles (defined as the inability to extend the knee to less than 20° of knee flexion) were randomly assigned to the control group or one of the 3 intervention groups Interventions: The three experimental groups was stretched for 15, 30, and 60 seconds, respectively the control group did not stretch Main Outcome Measures: The neurophysiological outcome measures included peak to peak somatosensory evoked potential for dermatomes L3,L4,L5, and S1. Secondary outcome measures included knee ROM. All outcome measures were assessed immediately after the treatment session and 24 hours after the treatment session.

Description:

A prospective, blinded, parallel-group, randomized clinical trial will be conducted in the research laboratory of our university. The patients will participate in the study after signing an informed consent form prior to data collection. Inclusion Criteria Subjects who demonstrate "tight" hamstring muscles, defined as inability to extend the knee to less than 20 degrees of knee flexion with the femur held at 90 degrees of hip flexion while the person was positioned supine. Subjects will also be screened to rule out knee joint flexion contractures by checking knee extension ROM, while they were lying in a prone position Exclusion Criteria Using of medical aids, and suffering from any neurological or cognitive impairment, limiting cardio-respiratory conditions, or had undergone recent surgery (within the past 12 months). Having any hip or knee replacements or any history of pathology in the low back, hips, or knees for the 3 months prior to the study Participants will be divided into four groups according to the stretching duration time (15, 30, and 60s, and the fourth group, which served as a control, did not stretch). The patients will randomly assigned to one of the four groups as follows. The randomization process will be based on permuted blocks of variable sizes. Each random permuted block, created randomly by a number generator, will be transferred to a sequence of consecutively numbered, opaque, sealed envelopes that will be kept in a locked drawer until needed. Once a subject was formally included in the trial, the next envelope in the sequence was opened by the researcher in the presence of the subject who would be assigned to a group according to the number found in the envelope.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 20, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 65 Years

Eligibility

Inclusion Criteria:

• Subjects with "tight" hamstring muscles, defined as inability to extend the knee to less than 20 degrees of knee flexion with the femur held at 90 degrees of hip flexion while the person was positioned supine.

Exclusion Criteria:

• Using of medical aids.
• suffering from any neurological or cognitive impairment, limiting cardio-respiratory conditions,
• had undergone recent surgery (within the past 12 months).
• Having any hip or knee replacements or any history of pathology in the low back, hips, or knees for the 3 months prior to the study

Related Conditions & MeSH terms

• Physical and Rehabilitation Medicine

Intervention

Other:
• stretching exercise
Static stretching consists of stretching a muscle (or group of muscles) to its farthest point and then maintaining or holding that position

Locations

Country	Name	City	State
United Arab Emirates	Ibrahim Moustafa	Sharjah	United Arab Emirate

Sponsors (1)

Lead Sponsor	Collaborator
University of Sharjah

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in dermatomal somatosensory evoked potentials immediately after treatment	In all dermatomes, 2 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 stimulated dermatomes being stimulated. The impedance of ground and scalp electrodes will be maintained at < 5 k Cutaneous areas of L3,L4,L5, S1 sensory roots will be stimulated in lower limb with the electrical impulses of 0.2 ms duration, frequency of 3.3 Hz and intensity 3 times higher than the sensory threshold will be determined individually for each subject.	pre-treatment , immediately after treatment and at 24 hours after the treatment .
Secondary	change in range of motion	Each subject will then be measured for knee extension ROM . Measurement of knee extension ROM was made with the subject lying supine with the opposite lower extremity extended and the lower extremity being measured positioned at 90 degrees of hip flexion. The greater trochanter and the lateral epicondyle of the femur and lateral malleolus will be palpated and served as landmarks during measurement, The measurement recorded will be the angle between the leg position and full knee extension (considered to be 0°). Because knee joint contractures will be ruled out, the measurement of knee extension ROM was considered to be an indirect measure of hamstring muscle flexibility, with hamstring muscle tightness being the purported cause of a lack of knee extension ROM.	pre-treatment , immediately after treatment and at 24 hours after the treatment .