Effectiveness of Muscles Energy Technique in the Management of Chronic Non-specific Low Back Pain

NCT03449810 | Completed DMC

• 1 other identifier: 217077488
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

Low back pain is the most common health problem that affects work performance and quality of life. Non-specific low back pain (NSLBP) is defined as low back pain not attributable to a recognizable, known specific pathology. NSLBP is the leading cause of disability among the major musculoskeletal conditions which leads to Impairments, Activity Limitations and participation restrictions. Therefore it becomes a psychosocial/economic burden on individuals, families, communities, industries and government. Existing literature shows globally 40% to 50% of people have LBP at some point in their lives and there exists a challenge in Africa on the best rehabilitation methods for low back pain management which could prevent chronic pain and disability. Therefore, this study aims to determine the effectiveness of MET when combined with DSE in the management of chronic NSLBP patients and to analyze the additional effect the MET procedure will provide relative to DSE.

Conditions

Chronic Non-specific Low Back Pain

Keywords

MET, Low Back Pain, Stabilization exercises; Quality of Life, Functional disability

Outcome Measures

Primary Outcomes (2)

• Medical Outcomes Survey Short-Form-36 (SF-36)

  Quality of Life (QoL) will be assessed with SF-36, The questionnaire is divided into 10 segments with a total of 36 questions. The segments involve Demography, General Health, Limitation of Activities, Physical Health Problem, Emotional Health Problem, Social Activities, Pain, Energy and Emotion, Social Activities and General Health.

  6 month

• Activity Limitation and Participation Restriction

  Level of activity Limitation and Participation Restriction would be measured using Orebro Musculoskeletal Pain Screening Questionnaire.

  6 month

Secondary Outcomes (10)

• Basal Mass Index (Demographic data)

  Once

• Skin fold thickness for percentage body fat (Demographic data)

  Once

• Transverse abdominus muscles contraction rate

  6 months

• Level of pain perception

  6 months

• Functional Disability

  6 months

Study Arms (3)

DSE plus MET (group A)

EXPERIMENTAL

The DSE will consist of seven exercise activities that will be administered at random viz; 1. Bridging 2. Supine twist stretch 3. Double leg knee to chest stretch 4. Plank heel raise 5. Ball squat 6. Leg press on ball 7. Hip Lifts. The MET procedure will involve a total of 5-10 contralateral isometric voluntary contractions that will be resisted by force equal to the participant's for 30 seconds with 5 seconds rest between contractions (corresponding to 20-30%).

Procedure: DSE plus MET group A

DSE only (group B)

ACTIVE COMPARATOR

The DSE will consist of seven exercise activities that will be administered at random viz; 1. Bridging 2. Supine twist stretch 3. Double leg knee to chest stretch 4. Plank heel raise 5. Ball squat 6. Leg press on ball 7. Hip Lifts.

Procedure: DSE alone group B

Standard Physiotherapy Treatment (group C)

ACTIVE COMPARATOR

This group will involve classical massage, therapeutic exercises (strengthening spinal and abdominal muscles) and a combination of interferential therapy and therapeutic ultrasound (INF/UTS) applied to the lumbosacral region. The participants will be asked to perform the therapeutic exercises once a day at home.

Procedure: Standard Physiotherapy treatment group C

Interventions

DSE plus MET group A PROCEDURE

The Dynamic stabilization exercises will consist of seven exercises, which are aimed to strengthen the lumbar stabilizing muscles. All seven dynamic stabilization exercises will be performed once and always in random order. The procedure for MET involves voluntary contraction of the participant's muscle in a precisely controlled direction, at varying levels of intensity, against a distinctly executed counterforce applied by the therapist. In this type of therapy, a participant contracts muscles by pushing against resistance provided by the therapist. The therapist then assists the participant in stretching, strengthening and relaxing those muscles.

DSE plus MET (group A)

DSE alone group B PROCEDURE

The DSE in this arm is the same a described in group A, i.e. it involves seven exercises activities administered randomly at every session of the study intervention.

DSE only (group B)

Standard Physiotherapy treatment group C PROCEDURE

In the control group, the participants will receive standard physiotherapy treatment offered for the management of chronic NSLBP patients in Nigeria. Therefore, individuals randomized to this therapeutic group will be treated with classical massage, therapeutic exercises and a combination of interferential therapy and therapeutic ultrasound (INF/UTS) applied to the lumbosacral region.

Standard Physiotherapy Treatment (group C)

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• NSLBP history of about or more than 3 months and associated with referred lower extremity pain; pain in the lumbopelvic region;
• Lumbar hypomobility; mobility deficits of the thorax and hip regions;
• LBP not of specific origin diagnosed by a physician (due to fracture, tumours, malignancy, ankyloses, infections, and pregnancy);
• Diminished trunk or pelvic region muscle strength and endurance;
• Movement coordination impairments while performing community/work-related recreational or occupational activities.
• Attending Outpatient clinics and Physiotherapy departments of Rasheed Shekoni Teaching Hospital Dutse and Federal medical centre Birnin-Kudu in Jigawa state, Northwest Nigeria.

You may not qualify if:

• Chronic NSLBP with radiating pain due to nerve root involvement in physical examination.
• Patients using immunosuppression or steroid medication.
• Patients with persistent severe pain.
• Patients with spinal deformities.
• Patients with widespread neurological symptoms; patients with peritonitis as at the time of recruitment; patients with a history of lumbar surgery; patients diagnosed with carcinoma or organ disease; and patients with a history of severe rheumatic, orthopaedic, cardiovascular, systemic, metabolic or neurologic disorders.

Sponsors & Collaborators

• University of KwaZulu: lead

Study Sites (1)

Rasheed Shekoni Specialist Hospital

Dutse, Jigawa State, 7200, Nigeria

Location

Related Publications (17)

• Koes BW, van Tulder MW, Thomas S. Diagnosis and treatment of low back pain. BMJ. 2006 Jun 17;332(7555):1430-4. doi: 10.1136/bmj.332.7555.1430. No abstract available.

  PMID: 16777886 BACKGROUND

• Manusov EG. Evaluation and diagnosis of low back pain. Prim Care. 2012 Sep;39(3):471-9. doi: 10.1016/j.pop.2012.06.003.

  PMID: 22958556 BACKGROUND

• Balague F, Mannion AF, Pellise F, Cedraschi C. Non-specific low back pain. Lancet. 2012 Feb 4;379(9814):482-91. doi: 10.1016/S0140-6736(11)60610-7. Epub 2011 Oct 6.

  PMID: 21982256 BACKGROUND

• Hoy D, Bain C, Williams G, March L, Brooks P, Blyth F, Woolf A, Vos T, Buchbinder R. A systematic review of the global prevalence of low back pain. Arthritis Rheum. 2012 Jun;64(6):2028-37. doi: 10.1002/art.34347. Epub 2012 Jan 9.

  PMID: 22231424 BACKGROUND

• Louw QA, Morris LD, Grimmer-Somers K. The prevalence of low back pain in Africa: a systematic review. BMC Musculoskelet Disord. 2007 Nov 1;8:105. doi: 10.1186/1471-2474-8-105.

  PMID: 17976240 BACKGROUND

• Omokhodion FO. Low back pain in an urban population in Southwest Nigeria. Trop Doct. 2004 Jan;34(1):17-20. doi: 10.1177/004947550403400107.

  PMID: 14959964 BACKGROUND

• Sikiru L, Shmaila H. Prevalence and risk factors of low back pain among nurses in Africa: Nigerian and Ethiopian specialized hospitals survey study. East Afr J Public Health. 2009 Apr;6(1):22-5. doi: 10.4314/eajph.v6i1.45737.

  PMID: 20000059 BACKGROUND

• Cohen SP, Argoff CE, Carragee EJ. Management of low back pain. BMJ. 2008 Dec 22;337:a2718. doi: 10.1136/bmj.a2718. No abstract available.

  PMID: 19103627 BACKGROUND

• Martell BA, O'Connor PG, Kerns RD, Becker WC, Morales KH, Kosten TR, Fiellin DA. Systematic review: opioid treatment for chronic back pain: prevalence, efficacy, and association with addiction. Ann Intern Med. 2007 Jan 16;146(2):116-27. doi: 10.7326/0003-4819-146-2-200701160-00006.

  PMID: 17227935 BACKGROUND

• Mitchell, F. L., & Mitchell, P. K. G. (1999). The muscle energy manual, 4196(517), 48826.

  BACKGROUND

• Franke H, Fryer G, Ostelo RW, Kamper SJ. Muscle energy technique for non-specific low-back pain. Cochrane Database Syst Rev. 2015 Feb 27;2015(2):CD009852. doi: 10.1002/14651858.CD009852.pub2.

  PMID: 25723574 BACKGROUND

• Marshall PW, Murphy BA. Core stability exercises on and off a Swiss ball. Arch Phys Med Rehabil. 2005 Feb;86(2):242-9. doi: 10.1016/j.apmr.2004.05.004.

  PMID: 15706550 BACKGROUND

• Hodges PW. Core stability exercise in chronic low back pain. Orthop Clin North Am. 2003 Apr;34(2):245-54. doi: 10.1016/s0030-5898(03)00003-8.

  PMID: 12914264 BACKGROUND

• Charan J, Biswas T. How to calculate sample size for different study designs in medical research? Indian J Psychol Med. 2013 Apr;35(2):121-6. doi: 10.4103/0253-7176.116232.

  PMID: 24049221 BACKGROUND

• Delitto A, George SZ, Van Dillen L, Whitman JM, Sowa G, Shekelle P, Denninger TR, Godges JJ; Orthopaedic Section of the American Physical Therapy Association. Low back pain. J Orthop Sports Phys Ther. 2012 Apr;42(4):A1-57. doi: 10.2519/jospt.2012.42.4.A1. Epub 2012 Mar 30.

  PMID: 22466247 BACKGROUND

• Selkow NM, Grindstaff TL, Cross KM, Pugh K, Hertel J, Saliba S. Short-term effect of muscle energy technique on pain in individuals with non-specific lumbopelvic pain: a pilot study. J Man Manip Ther. 2009;17(1):E14-8. doi: 10.1179/jmt.2009.17.1.14E.

  PMID: 20046557 BACKGROUND

• Ahmed UA, Maharaj SS, Van Oosterwijck J. Effects of dynamic stabilization exercises and muscle energy technique on selected biopsychosocial outcomes for patients with chronic non-specific low back pain: a double-blind randomized controlled trial. Scand J Pain. 2021 Feb 24;21(3):495-511. doi: 10.1515/sjpain-2020-0133. Print 2021 Jul 27.

  PMID: 33641272 DERIVED

Related Links

• Koes, B. W., Van Tulder, M. W., \& Thomas, S. (2006). Diagnosis and Treatment of Low Back Pain.
• Balagué, F., Mannion, A. F., Pellisé, F., \& Cedraschi, C. (2012). Non-specific low back pain.
• Louw QA, Morris LD, Grimmer-Somers K. The prevalence of low back pain in Africa: a systematic review
• Sikiru, L., \& Shmaila, H. (2009). Prevalence and risk factors of low back pain among nurses in Africa: Nigerian and Ethiopian specialized hospitals survey study
• Cohen SP, Argoff CE, Carragee EJ. Management of low back pain.
• Marshall, P. W., \& Murphy, B. A. (2005). Core stability exercises on and off a Swiss ball.
• Hodges, P. W. (2003). Core stability exercise in chronic low back pain.
• ANOVA power analysis

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• USMAN ABBA AHMED, MASTERS

  University of KwaZulu

  PRINCIPAL INVESTIGATOR

• Maharaj S Sonill, PhD

  University of KwaZulu

  STUDY CHAIR

• Nadasan N Thaya, PhD

  University of KwaZulu

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: All eligible participants will be randomly be allocated to three groups using a random number generator by an independent person (third party). Two study assessors will take measurements of all outcomes at baseline, 6th and 12th week and 3 months follow-up, however, they will be blinded to group allocation. Group indication will be placed in a sealed envelope that will be opened after the study assessors have performed the initial assessments and the participants will be instructed not to disclose their study groups to the assessors. However, participants are expected to be unaware of their group procedure/intervention, therefore, the physiotherapists will be instructed not to disclose the name of their group procedure to the participants.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The Intervention Models Includes; Muscles Energy Technique plus Dynamic stabilization exercises which would be administered to participants in group A, Dynamic stabilization exercises to be administered to group B participants and group C which is the control will receive standard physiotherapy treatment.

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: February 28, 2018
• Study Start: January 1, 2019
• Primary Completion: October 14, 2019
• Study Completion: December 20, 2019
• Last Updated: July 26, 2021

Record last verified: 2021-07

Locations

NG (1)