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Mechanical Low Back PainNCT04156776

Comparison of MET and AIS on Erector Spinae Muscle in Low Back Pain

A study testing Muscle Energy Technique, Active Isolated Stretching and Conventional Treatment in people with Mechanical Low Back Pain, 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

The main objective of the study was to compare the effectiveness of Muscle Energy Technique and Active Isolated Stretching on Erector Spinae Muscle in the management of Mechanical Low back Pain (LBP) and to find out that which technique is better for the treatment of mechanical LBP Read more about this study

Who is it for?
Ages 35 to 55 years
Conditions the study is for
Mechanical Low Back Pain
What is being tested?
Muscle Energy Technique, Active Isolated Stretching and Conventional Treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
1 sitePakistan
Study dates
12 Jul 2018to 25 Feb 2019
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 35 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients having acute mechanical LBP.
  • Patients having restricted ROM.

Who cannot join

  • Patients with ankylosing spondylitis.
  • Patient undergone any spinal surgery.
  • Patient having scoliosis.
  • Patient with tumor.
  • Patient with Rheumatoid Arthritis and other systemic diseases.
  • Immobile/ Bed ridden patients.
  • Patients with cognitive Problems. 8. Patients having vertebral compression fracture. 9. Patients with slump test positive.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Riphah International University

    Islamabad, 44000

Other trials in Pakistan

About this study

Official title: Comparison Of Muscle Energy Technique And Active Isolated Stretching On Erector Spinae Muscle In The Management Of Mechanical Low Back Pain

The main objective of the study was to compare the effectiveness of Muscle Energy Technique and Active Isolated Stretching on Erector Spinae Muscle in the management of Mechanical Low back Pain (LBP) and to find out that which technique is better for the treatment of mechanical LBP

Read the detailed description

Lumbar spine "mobilization and manipulation" relieves the hypomobility in the intervertebral joints which results in pain reduction and significant improvement in lumbar spine ROMs. In dry needling, trigger point is palpated and tiny needle is inserted in hyperirritable point. Local twitch response is noted. Referred pain pattern may appear followed by pain relief and trigger point release. In this technique, pain is relieved by spontaneous positioning and maintains a non-painful tension in hypertonic muscle. When subject is placed in a non-tension position pain is decreased up to 70%. In Instrument assisted soft tissue mobilization: Various instruments like beveled edges,tools are used for soft tissue mobilization and decreasing pain threshold.

MUSCLE ENERGY TECHNIQUE (MET) is actually a sort of "myofascial release soft-tissue method" in which the patient is given a command to use the muscles actively in a direction opposite to the force applied by the therapist which results in the enhancement of joint ROM and flexibility. In MET, "sub-maximal active resisted isometric contraction of muscle" is performed for couple of times after that the muscle is stretched passively which results in the increment in ROM, desired muscular length and flexibility.

The concept which is used in MET is the reciprocal inhibition in which "the muscle which is faulty placed in mid range and the practitioner resists the greatest power either isotonically or isometrically". The patient is instructed to breathe in with the application of force and breathe out as the muscle is being lengthened For convenience, therapeutic exercises and specialized manual therapy treatment protocols can be divided into two main levels although the treatment of LBP depends on the condition of patient, intensity of pain, diagnosis and signs and symptoms. First level includes therapeutic exercises like "Range of Motion (ROM) exercises, stretching exercises, strengthening exercises and aerobic exercises" whereas second level includes advances manual therapy treatment protocols which includes specialised techniques like dry needling, strain counter strain, , lumbar stabilization exercises, MET, AIS etc When patient performs the exercises actively, nutritional supply gets enhanced to the soft tissues in lower back which keeps the vertebras, muscles, joints and ligaments sound. Lower back exercises keep the patient's spine healthy by maintaining its flexibility and strength and additionally, they decrease the chances of re-occurrence of LBP.

Most commonly advised back exercises by physical therapists in the management of low back pain are "aerobic conditioning, stretching exercises, and strengthening exercises, McKenzie Exercises and lumbar stabilization exercises Lower back stretching exercises increase ROM and improves flexibility. Literature also recommends to stretch "hamstrings, piriformis and gluteal muscles" once or twice a day. Stretching exercises includes hamstring stretch or straight leg raising (SLR), knee to chest stretch, piriformis muscle stretch, etc Lower back stretching exercises increase ROM and improves flexibility. Literature also recommends to stretch "hamstrings, piriformis and gluteal muscles" once or twice a day. Stretching exercises includes hamstring stretch or SLR, knee to chest stretch, piriformis muscle stretch, etc On alternate days, doing aerobic exercises for 30 to 40 minutes a day for three times in a week, helps in the long-term reduction of LBP because by these exercises, nutrition supply can be enhanced to the soft tissues which promotes healing. Such type of exercises includes "walking, jogging, bicycling, swimming, etc Mobilization of lumbar spine, electrotherapy treatment, Stretching and strengthening exercises, postural correction of the individuals which are suffering from LBP are routine treatment protocols. Conventional physical therapy treatment is effective as it decreases the pain and improves the patient's functional outcome for patients of chronic LBP, but erector spinae muscle length remains compromised. Muscle energy technique and Active isolated stretching technique are advanced treatment protocols for getting improvement in muscle length by which patients get better in few sessions.

Being tested
Muscle Energy Technique, Active Isolated Stretching, Conventional Treatment
Keywords
Active Isolated Stretching, Muscle Energy Technique, Mechanical Low Back Pain
Medical subject headings
Low Back Pain

What participants receive

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

  • Muscle Energy TechniqueOther

    Muscle energy technique was repeated 4 times per session every day for 3 days a week for 4 weeks after the application of moist heating pad for 30 minutes before each session.

  • Active Isolated StretchingOther

    The patient was asked to sit in an upright seated position and flex his/her knees 12 to 18 inches. Patient was asked to tuck the chin, exhale, and firmly contract the abdominal muscles as he/she curls their body forward. He/she was also guided not to bounce or make rapid movements at the end range of the active motion. Then, he was asked to move back to the starting position and repeat the same procedure for 8 to 10 times. Stretch on the end range was not more than 2 seconds.

    This technique was repeated 10 times per session every day for 3 days a week for 4 weeks after the application of moist heating pad for 30 minutes before each session.

  • Conventional TreatmentOther

    Conventional physical therapy treatment includes the application of moist heating pad for 30 minutes on lower back/ lumbar region prior to the intervention to both groups.

Study groups in NCT04156776
Study groupRoleWhat they receive
Group A (MET)ExperimentalMuscle Energy Technique Conventional Treatment
Receives: Other: Muscle Energy Technique; Other: Conventional Treatment
Group B (AIS)ExperimentalActive Isolated Stretching Conventional Treatment
Receives: Other: Active Isolated Stretching; Other: Conventional Treatment

What is being measured

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

  1. Erector Spinae Muscle Length through Measuring Tape

    The length of the erector spinae can be evaluated in seated position with the legs fully flexed off the end of the table. The therapist stands behind the patient and palpates the anterior superior iliac spine (ASIS) bilaterally. The patient was taught and instructed to perform a posterior pelvic tilt, thus flattening the lumbar lordosis by creating lumbar flexion. Then, the patient was instructed to flex forward, attempting to bring the forehead to the knees. The practitioner feels for when the ASIS of the patient begins to move, which would indicate the end of thoracolumbar flexion and would indicate the initiation of an anterior pelvic tilt.

    Patient's forehead should come within 10 inches of the knees. The therapist had to note that no knee flexion occurred and the movement is coming from the thoracolumbar spine only.

    In the current study, erector spinae muscle length was measured prior starting the treatment as well as after completing the last treatment session.

    Measured: 4th week

  2. Oswestry Disability Index (ODI)

    ODI is the tool to measure the level of disability in essential conditions. This scale totally focuses on the evaluation of disability and impairment caused due to LBP. It contains 10 questions which are easily understandable. The very first question in the questionnaire is about the intensity of pain while next questions are about the level of disability and impairment caused on activity of daily living (ADLs) which includes "sleep, lifting, walking, sex life, sitting and so forth." Score for each question is from zero, which indicates no intensity, to five which indicates greatest inability due to LBP. Total obtained score of ten questions was calculated which was divided by the total possible score (i.e., 50) and then it was multiplied by hundred. The answer was in percentage. Let's assume, the total score of the patient was 20 and total possible score is 50 then 20/50 x 100 = 40 %.

    Measured: 4th week

  3. Numeric Pain Rating Scale (NPRS)

    NPRS is a tool to measure the pain intensity. Frequently, pain is the main concern of the patient which compelled him/ her to pursue treatment and NPRS is essential tool to gauge pain intensity in routine practice although psychological aspects of pain can also be considered. NPRS contains eleven levels from zero, which presents "no pain", till ten which presents the "worst pain" one can feel, as shown in figure 11. NPRS is an exceptionally easy to quantify pain, can be used by the patient him self and even it can likewise be utilized in people with low proficiency. It is utilized routinely in numerous nations and languages.

    Measured: 4th week

Secondary outcomes (1)
  1. Lumbar Spine ROM through Inclinometer

    Lumbar spine range of motion was performed in standing position with help of "inclinometer". The "American Medical Association" issued the guidelines in which the use of inclinometers has been declared as "a feasible and potentially accurate method of measuring spine mobility." In current study, dual- inclinometer method was used to measure the lumbar spine ROM of "flexion, extension, right and left side bending" prior starting the treatment as well as after completing the last treatment session. Diseases of lumbar spine, spinal muscular issues reduce the lumbar spine ROM. ROM values for normal lumbar spine.

    Patient was in standing position. Baseline inclinometer was placed on the "midline of spine in line with Posterior superior iliac spine (PSIS)" and superior inclinometer was placed "15 cm above baseline landmark". Patient was asked to flex the spine as much as he/she can. Inclinometers was placed in above mentioned points by the therapist till the end of possible ROM.

    Measured: 4th week

Timeline

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

  1. First posted7 Nov 2019
  2. Study start12 Jul 2018
  3. Primary completion10 Dec 2018
  4. Study completion25 Feb 2019

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
Model description
Group A (MET) and Group B (AIS)
Masking
Single blind
Who is masked
Participant
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04156776
Sponsor's protocol ID
RiphahIU Hanan Zafar-REC/00387
Status last verified
Jan 2020
First submitted
6 Nov 2019
Last updated
10 Jan 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ali, S., et al., CHRONIC LOW BACK PAIN; EFFECTS OF THE LUMBAR STABILIZATION EXERCISES ON PAIN, RANGE OF MOTION AND FUNCTIONAL DISABILITY IN THE MANAGEMENT. Professional Medical Journal, 2017. 24(4).

  • Lawrence RC, Helmick CG, Arnett FC, Deyo RA, Felson DT, Giannini EH, Heyse SP, Hirsch R, Hochberg MC, Hunder GG, Liang MH, Pillemer SR, Steen VD, Wolfe F. Estimates of the prevalence of arthritis and selected musculoskeletal disorders in the United States. Arthritis Rheum. 1998 May;41(5):778-99. doi: 10.1002/1529-0131(199805)41:53.0.CO;2-V.

    PubMed 9588729
  • Hoy D, March L, Brooks P, Blyth F, Woolf A, Bain C, Williams G, Smith E, Vos T, Barendregt J, Murray C, Burstein R, Buchbinder R. The global burden of low back pain: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis. 2014 Jun;73(6):968-74. doi: 10.1136/annrheumdis-2013-204428. Epub 2014 Mar 24.

    PubMed 24665116
  • Hoy D, March L, Brooks P, Woolf A, Blyth F, Vos T, Buchbinder R. Measuring the global burden of low back pain. Best Pract Res Clin Rheumatol. 2010 Apr;24(2):155-65. doi: 10.1016/j.berh.2009.11.002.

    PubMed 20227638
  • Chien JJ, Bajwa ZH. What is mechanical back pain and how best to treat it? Curr Pain Headache Rep. 2008 Dec;12(6):406-11. doi: 10.1007/s11916-008-0069-3.

    PubMed 18973732
  • Endean A, Palmer KT, Coggon D. Potential of magnetic resonance imaging findings to refine case definition for mechanical low back pain in epidemiological studies: a systematic review. Spine (Phila Pa 1976). 2011 Jan 15;36(2):160-9. doi: 10.1097/BRS.0b013e3181cd9adb.

    PubMed 20739918
  • Linton SJ. The relationship between activity and chronic back pain. Pain. 1985 Mar;21(3):289-294. doi: 10.1016/0304-3959(85)90092-2.

    PubMed 3157914
  • Okunribido OO, Magnusson M, Pope MH. The role of whole body vibration, posture and manual materials handling as risk factors for low back pain in occupational drivers. Ergonomics. 2008 Mar;51(3):308-29. doi: 10.1080/00140130701637262.

    PubMed 18311609
  • Drake, R., A.W. Vogl, and A.W. Mitchell, Gray's Anatomy for Students E-Book. 2009: Elsevier Health Sciences

  • Galbusera, F. and H.-J. Wilke, Biomechanics of the Spine: Basic Concepts, Spinal Disorders and Treatments. 2018: Academic Press

  • Frankel VH. Biomechanics of the musculoskeletal system. Introduction. Arch Surg. 1973 Sep;107(3):405. doi: 10.1001/archsurg.1973.01350210041013. No abstract available.

    PubMed 4783034
  • Adrian, M. and J.M. Cooper, Biomechanics of human movement. 1995: Brown & Benchmark

  • Kaltenborn, F.M., et al., Manual Mobilization of the Joints: The Spine. 2009: Orthopedic Physical Therapy

  • Cramer, G.D. and S.A. Darby, Clinical Anatomy of the Spine, Spinal Cord, and ANS. 2017: Elsevier Health Sciences

  • Hans, J., D. Kachlík, and R.S. Tubbs, An Illustrated Terminologia Neuroanatomica: A Concise Encyclopedia of Human Neuroanatomy. 2018: Springer

Questions about this trial

What is this clinical trial studying?

A study testing Muscle Energy Technique, Active Isolated Stretching and Conventional Treatment in people with Mechanical Low Back Pain, 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 2 inclusion and 7 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 10 Jan 2020. 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?

Erector Spinae Muscle Length through Measuring Tape (time frame: 4th week). The study lists 3 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 NCT04156776, which also lists 68 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 10 Jan 2020.

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