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Low Back Pain, MechanicalNCT06406894

Effect of Superficial Back Line Relaxation Technique on Hamstring Flexibility in Non Specific Low Back Pain Patients

A study testing Conventional physical therapy and Superficial back line relaxation (SMIT & CCFE) in people with Low Back Pain, Mechanical and Hamstring Flexibility, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 30 to 50 years
What is being tested?
Conventional physical therapy and Superficial back line relaxation (SMIT & CCFE)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 sitePakistan
Study dates
1 Mar 2024to 1 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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°

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Railway General hospital

    Rawalpindi, Punjab Province, 46000

Other trials in Pakistan

About this study

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.

Read the detailed 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.

Being tested
Conventional physical therapy, Superficial back line relaxation (SMIT & CCFE)
Keywords
hamstring flexibility, backache, Suboccipital muscle inhibition technique, cranial cervical flexion exercise
Medical subject headings
Low Back Pain, Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conventional physical therapyOther

    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)Other

    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).

Study groups in NCT06406894
Study groupRoleWhat they receive
superficial back line relaxationExperimentalsuboccipital muscle inhibition, cranial cervical flexion exercise
Receives: Other: Superficial back line relaxation (SMIT & CCFE)
Conventional physical therapyActive comparatorhot packs, muscle stretching exercise of lowerlimb ( Pelvic bridging, knee to chest, Cat and camel stretch)
Receives: Other: Conventional physical therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3rd week

  2. 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%.

    Measured: 3rd week

  3. 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

    Measured: 3rd week

  4. 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%.

    Measured: 3rd week

Secondary outcomes (2)
  1. 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..

    Measured: 3rd week

  2. 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.

    Measured: 3rd week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2024
  2. Study start1 Mar 2024
  3. Primary completion1 Jun 2024
  4. Study completion1 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06406894
Sponsor's protocol ID
REC/MS-PT/01797
Status last verified
Nov 2024
First submitted
6 May 2024
Last updated
22 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25642072
  • 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.

    PubMed 25606860
  • 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.

    PubMed 25031677
  • 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.

    PubMed 25165395
  • 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.

    PubMed 22196432
  • 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.

    PubMed 22294848
  • 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.

    PubMed 19632880
  • 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.

    PubMed 30248030
  • 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.

    PubMed 23785569
  • 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.

    PubMed 24725797
  • 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.

    PubMed 22517215

Questions about this trial

What is this clinical trial studying?

A study testing Conventional physical therapy and Superficial back line relaxation (SMIT & CCFE) in people with Low Back Pain, Mechanical and Hamstring Flexibility, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Politeal angle ( Hip flexion with knee extension range) (time frame: 3rd week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06406894, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.

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