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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06406894
Other study ID # REC/MS-PT/01797
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2024
Est. completion date June 1, 2024

Study information

Verified date May 2024
Source Riphah International University
Contact Imran Amjad, Phd
Phone 03324390125
Email imran.amjad@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Current study aim to evaluate the effect of Superficial back line relaxation techniques (SMIT along with CCFE) In Non Specific Low back Pain Patients in order to improve pain and hamstring flexibility. And To find out the association between sub occipital muscle inhibition technique (SMIT) and cranial cervical flexion exercise (CCFE) in nonspecific low back pain patients with hamstring tightness. The study aims to enhance the functional status and posture of patients suffering from nonspecific low back pain due to hamstring tightness, thereby enhancing patient efficiency in performing ADLS and IADLS.


Description:

According to recent studies, hamstring tightness gets better as a result of sub occipital muscle inhibition technique, and cranial cervical flexion exercise that improve hamstring flexibility. SMIT is an approach of releasing fascia by application of pressure on sub occipital area. The myofascia relaxes as tone of suboccipital muscle declines that results in reduction in hamstring tone effectively.This is so because the superficial back line of dura matter connects hamstring with sub occipital muscles and neurological system runs through it. In SMIT superficial back line relaxes. While this approach helps suboccipital muscles release degree tension between occiput and axis. The premise behind CCFE is that cervical spine's dura matter and suboccipital muscle fascia are connected by soft tissue while superficial back line of myofascial chain connects the neck to lower extremity. If tone of suboccipital muscle is reduced,the tone of knee flexors gets minimize and degree of hip flexion gets increase that results in increasing hamstring flexibility. Previous study showed that CCFE restores hamstring flexibility by relaxing superficial back line. While SMI and CCFE represents passive and active exercise program, respectively are equally effective in immediate enhancement of hamstring flexibility. This study divide in to two groups. Group A ( experimental group) and Group B ( control group). Group A will receive manual technique superficial back line relaxation technique includes (Suboccpital muscle inhibition along with cranial cervical flexion Exercise) with conventional therapy.While group B will receive only conventional therapy include hot pack (lumber region) with low back exercises such as stretching exercise (knee to chest, Pelvis bridging, Cat and camel stretch). Current study aims to pin point combine effect of SMIT along with CCFE in people with hamstring tightness. Additionally this study will evaluate the immediate and long term effect of SMIT and CCFE on patients with non- specific low back pain by comparing direct and indirect approaches for hamstring flexibility. The study aims to enhance the functional status and posture of patients suffering from nonspecific low back pain due to hamstring tightness, thereby enhancing patient efficiency in performing ADLS and IADLS.


Recruitment information / eligibility

Status Recruiting
Enrollment 44
Est. completion date June 1, 2024
Est. primary completion date June 1, 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years to 55 Years
Eligibility Inclusion Criteria: - Patients with chronic low back pain associate with hamstring tightness. - Unilateral or bilateral short hamstring syndrome - 3 to 6 points in numeric pain rating scale(NPRS). - Active knee extension more than 20°. - Presence of hamstring tightness with Popliteal angle more than 30 degree. - Angle in SLR test should be less than 80° Exclusion Criteria: - History of cervical spine surgery and neck trauma. - Cervical and lumber spinal deformity, Herniated disc or protrusions, Spinal stenosis. - Muscle tendon injuries of the hamstring. - History of vascular disease in head and neck. - Visual swelling in the region of hamstring muscle. - Progressive neurological deficit. - Fractures in cervical and lumber spine. - Past and current history of vertigo and dizziness.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Conventional physical therapy
lower limb muscle stretching ( pelvic bridging, Knee to chest,cat and camel stretch) (30 seconds hold and 3 sets of 5 repetitions with 1 min rest interval in between each set, per session on daily basis for only one week for immediate results and for long term effect on alternate 3 days in remaining 2nd ,3rd week). Treatment protocol will be given on daily basis to check immediate effect and for long term effect treatment will be given in alternating 3 days for remaining 2 weeks. Total 12 session were given (3 weeks).
Superficial back line relaxation (SMIT & CCFE)
Experimental group was given superficial back line relaxation includes SMIT & CCFE along with conventional therapy includes lower limb muscle stretching. SMIT For short term effect 10-12 repetitions per session, on daily basis for 1st week. For long term effect 10-12 repetitions per session, for 3 alternate days in remaining 2nd&3rd week. CCFE For short term effect 3 sets of 10 reps , 10 sec hold , 1 min rest after each set, on daily basis for 1st week. For long term effect 3 sets of 10 reps, 10 sec hold , 1 min rest after each set, for 3 alternate days , remaining 2nd & 3rd week. Conventional therapy lower limb muscle stretching ( For short term effect 30 seconds hold , 3 sets of 5 repetitions , 1 min rest after each set, per session on daily basis for 1st week , for long term effect on alternate 3 days in remaining 2nd ,3rd week). Total 12 sessions were given (3 weeks).

Locations

Country Name City State
Pakistan Railway General hospital Rawalpindi Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (11)

Ajimsha MS, Daniel B, Chithra S. Effectiveness of myofascial release in the management of chronic low back pain in nursing professionals. J Bodyw Mov Ther. 2014 Apr;18(2):273-81. doi: 10.1016/j.jbmt.2013.05.007. Epub 2013 Jun 5. — View Citation

Cho SH, Kim SH, Park DJ. The comparison of the immediate effects of application of the suboccipital muscle inhibition and self-myofascial release techniques in the suboccipital region on short hamstring. J Phys Ther Sci. 2015 Jan;27(1):195-7. doi: 10.1589/jpts.27.195. Epub 2015 Jan 9. — View Citation

Coenen P, Gouttebarge V, van der Burght AS, van Dieen JH, Frings-Dresen MH, van der Beek AJ, Burdorf A. The effect of lifting during work on low back pain: a health impact assessment based on a meta-analysis. Occup Environ Med. 2014 Dec;71(12):871-7. doi: 10.1136/oemed-2014-102346. Epub 2014 Aug 27. — View Citation

Hart DL, Stratford PW, Werneke MW, Deutscher D, Wang YC. Lumbar computerized adaptive test and Modified Oswestry Low Back Pain Disability Questionnaire: relative validity and important change. J Orthop Sports Phys Ther. 2012 Jun;42(6):541-51. doi: 10.2519/jospt.2012.3942. Epub 2012 Apr 19. — View Citation

Houston MN, Hodson VE, Adams KK, Hoch JM. The effectiveness of whole-body-vibration training in improving hamstring flexibility in physically active adults. J Sport Rehabil. 2015 Feb;24(1):77-82. doi: 10.1123/JSR.2013-0059. — View Citation

Jeong ED, Kim CY, Kim SM, Lee SJ, Kim HD. Short-term effects of the suboccipital muscle inhibition technique and cranio-cervical flexion exercise on hamstring flexibility, cranio-vertebral angle, and range of motion of the cervical spine in subjects with neck pain: A randomized controlled trial. J Back Musculoskelet Rehabil. 2018;31(6):1025-1034. doi: 10.3233/BMR-171016. — View Citation

Jull GA, Falla D, Vicenzino B, Hodges PW. The effect of therapeutic exercise on activation of the deep cervical flexor muscles in people with chronic neck pain. Man Ther. 2009 Dec;14(6):696-701. doi: 10.1016/j.math.2009.05.004. Epub 2009 Jul 25. — View Citation

Massoud Arab A, Reza Nourbakhsh M, Mohammadifar A. The relationship between hamstring length and gluteal muscle strength in individuals with sacroiliac joint dysfunction. J Man Manip Ther. 2011 Feb;19(1):5-10. doi: 10.1179/106698110X12804993426848. — View Citation

Rogan S, Wust D, Schwitter T, Schmidtbleicher D. Static stretching of the hamstring muscle for injury prevention in football codes: a systematic review. Asian J Sports Med. 2013 Mar;4(1):1-9. Epub 2012 Nov 20. — View Citation

Simmonds N, Miller P, Gemmell H. A theoretical framework for the role of fascia in manual therapy. J Bodyw Mov Ther. 2012 Jan;16(1):83-93. doi: 10.1016/j.jbmt.2010.08.001. Epub 2010 Sep 27. — View Citation

Strand SL, Hjelm J, Shoepe TC, Fajardo MA. Norms for an isometric muscle endurance test. J Hum Kinet. 2014 Apr 9;40:93-102. doi: 10.2478/hukin-2014-0011. eCollection 2014 Mar 27. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Politeal angle ( Hip flexion with knee extension range) Changes from baseline popliteal angle was taken with help of goniometer. The hamstring-popliteal angle measures hamstring flexibility by bending the hip and stretching the knee. It's passive and accurate, with a 98% reliability value. Adult popliteal angles typically fall between 80 and 90 degrees. If leg cannot reach this angle, stiffness may be present. 3rd week
Primary Straight leg raise SLR (Hip flexion ROM) Changes from baseline hip flexion ROM was taken with help of goniometer. Patient lies supine throughout the SLR test, and the assessor raises the subject's right leg. Patient should keep their leg straight during the evaluation. If the therapist senses resistance or the patient complains of pain, the therapist should halt and use goniometry to determine the angle of the lower leg and hip. The therapist need to be vigilance while measuring the angle to make sure the patient's ankle or pelvis does not rotate. This test's reliability for determining hamstring flexibility is 92%. 3rd week
Primary Active knee extension test Changes from baseline knee extension range was taken with help of goniometer. This test was performed to assess the hamstring muscle's flexibility.The length of the hamstring muscles was determined by measuring the angle of knee extension in degrees. This test has a 99% reliability rate when used to measure hamstring flexibility 3rd week
Primary Modified Sit and Reach test Common test of flexibility that evaluates the hamstring and lower back muscles' flexibility is the sit and reach test.The greatest distance a person can extend forward while seated in a fixed position is measured, and this is used to evaluate the stability of the patient.The sit-and-reach test's reliability rate for hamstring flexibility is 96%. 3rd week
Secondary Numeric pain rating scale(NPRS) Changes from baseline NPRS is a one-dimensional assessment of adult pain severity, where participants rate their discomfort using a segmented numeric version (0-10 integers) of the VAS. NPRS has a 96% reliability rate and an 85% validity rate.. 3rd week
Secondary Oswestry Disability Index (ODI) (ODI) is a widely used tool for measuring low back pain, assessing impairment in daily activities. It uses a questionnaire with 10 multiple-choice questions.Each question contains six possible answers, ranging from 0 to 5, indicating a person's ability to perform specific tasks. ODI has a 96% reliability rate. 3rd week
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