NCT06406894

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

March 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 9, 2024

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

November 22, 2024

Status Verified

November 1, 2024

Enrollment Period

3 months

First QC Date

May 6, 2024

Last Update Submit

November 19, 2024

Conditions

Keywords

hamstring flexibilitybackacheSuboccipital muscle inhibition techniquecranial cervical flexion exercise

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (2)

  • Numeric pain rating scale(NPRS)

    3rd week

  • Oswestry Disability Index (ODI)

    3rd week

Study Arms (2)

superficial back line relaxation

EXPERIMENTAL

suboccipital muscle inhibition, cranial cervical flexion exercise

Other: Superficial back line relaxation (SMIT & CCFE)

Conventional physical therapy

ACTIVE COMPARATOR

hot packs, muscle stretching exercise of lowerlimb ( Pelvic bridging, knee to chest, Cat and camel stretch)

Other: Conventional physical therapy

Interventions

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).

Conventional physical therapy

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).

superficial back line relaxation

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with chronic low back pain associate with hamstring tightness.
  • Unilateral or bilateral short hamstring syndrome
  • 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°

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Railway General hospital

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Related Publications (11)

  • 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.

    PMID: 25642072BACKGROUND
  • 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.

    PMID: 25606860BACKGROUND
  • 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.

    PMID: 25031677BACKGROUND
  • 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.

    PMID: 25165395BACKGROUND
  • 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.

    PMID: 22196432BACKGROUND
  • 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.

    PMID: 22294848BACKGROUND
  • 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.

    PMID: 19632880BACKGROUND
  • 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.

    PMID: 30248030BACKGROUND
  • 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.

    PMID: 23785569BACKGROUND
  • 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.

    PMID: 24725797BACKGROUND
  • 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.

    PMID: 22517215BACKGROUND

MeSH Terms

Conditions

Low Back PainBack Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sidra Ghais, Phd

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2024

First Posted

May 9, 2024

Study Start

March 1, 2024

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

November 22, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations