Myofascial Release and Mobilization With Impulse Technique Torsion in Low Back Pain

Low Back Pain Clinical Trial

Official title:

Effects of Myofascial Soft Tissue Release and Mobilization With Impulse Technique Torsion in Subjects With Chronic Non-specific Low Back Pain: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02065531
• Other study ID #: UAL-021
• Status: Completed
• Phase: Phase 1
• First received: January 10, 2014
• Last updated: November 23, 2014
• Start date: January 2014
• Est. completion date: November 2014

Study information

• Verified date: November 2014
• Source: Universidad de Almeria
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of the current randomized clinical trial was to compare the effectiveness of myofascial soft tissue release versus mobilization with impulse technique torsion (anterior) on pain, disability, and kinesiophobia in individuals with chronic non-specific low back pain.

Description:

Design: Randomized Clinical Trial. Objective: to determine the effects of myofascial soft tissue release versus mobilization with impulse technique torsion (anterior) on pain, disability and kinesiophobia in individuals with chronic non-specific low back pain.

Methods and Measures: sixty-four individuals will be randomly assigned to one of two groups.

Intervention: For 12-week, the group 1 will undergo treatment comprising a myofascial soft tissue release protocol (1/week) and the group 2 will receive a mobilization with impulse technique torsion (anterior) (1/week).

Main Outcome Measures: Intensity of pain, disability, fear of movement, isometric endurance of trunk flexor muscles and lumbar mobility in flexion data will be collected at baseline, and 24hr after the last manual therapy application. Mixed-model analyses of variance will be used to examine the effects of the treatment on each outcome measure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: November 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Score =4 on the Roland Morris Disability Questionnaire

• Inability to achieve lumbar muscle flexion-relaxation in trunk flexion

• Low back pain for =3 months

• Not undergoing another physical therapy treatment

Exclusion Criteria:

• Disease of the central or peripheral nervous system

• Having previously undergone spinal manipulative therapy

• Contraindication to low back thrust manipulation

• A history of spinal surgery

• Treatment with corticosteroid in the past two weeks

• Clinical signs of radiculopathy

• Presence of lumbar stenosis

• Diagnosis of spondylolisthesis

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Chronic Disease
• Low Back Pain

Intervention

Other:
• Myofascial Soft Tissue Release
Protocol: Transverse Plane-Level Clavicular Release. Diaphragmatic Transverse Plane Release. Square the Lumbar Fascia Release. Gluteal Fascia Release. Hint Of Pubic Region Release. Fascia Psoas Release. Lumbo-sacral Decompression. Pelvic Floor Release.
• Mobilization with impulse technique.
Subject in lateral decubitus with extension and lower limb traction contact the couch with contralateral lower limb was performed triple flexion and left trunk rotation. This technique reduces the slack (tension joints) of the ventral pelvis, head and into the contralateral side of the sacrum support (base) with the forearm.

Locations

Country	Name	City	State
Spain	Universidad de Almeria	Almería

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Almeria

Country where clinical trial is conducted

Spain, 

References & Publications (14)

Bachmann S, Oesch P. [Physiotherapy and rehabilitation for low back pain]. Ther Umsch. 2013 Sep;70(9):543-8. doi: 10.1024/0040-5930/a000444. Review. German. — View Citation

Cymet TC. Osteopathic manual treatment and ultrasound therapy for chronic low back pain: an illustration of osteopathic semantic confusion. J Am Osteopath Assoc. 2014 Jan;114(1):6-7. doi: 10.7556/jaoa.2014.002. — View Citation

Donaldson M, Learman K, O'Halloran B, Showalter C, Cook C. The role of patients' expectation of appropriate initial manual therapy treatment in outcomes for patients with low back pain. J Manipulative Physiol Ther. 2013 Jun;36(5):276-83. doi: 10.1016/j.jmpt.2013.05.016. — View Citation

Ebert R, Campbell A, Kemp-Smith K, O'Sullivan P. Lumbar spine side bending is reduced in end range extension compared to neutral and end range flexion postures. Man Ther. 2014 Apr;19(2):114-8. doi: 10.1016/j.math.2013.08.004. Epub 2013 Sep 4. — View Citation

Eirikstoft H, Kongsted A. Patient characteristics in low back pain subgroups based on an existing classification system. A descriptive cohort study in chiropractic practice. Man Ther. 2014 Feb;19(1):65-71. doi: 10.1016/j.math.2013.07.007. Epub 2013 Aug 6. — View Citation

Hands-on treatment helps low back pain. Harv Womens Health Watch. 2013 Jun;20(10):8. — View Citation

Haskins R, Osmotherly PG, Southgate E, Rivett DA. Physiotherapists' knowledge, attitudes and practices regarding clinical prediction rules for low back pain. Man Ther. 2014 Apr;19(2):142-51. doi: 10.1016/j.math.2013.09.005. Epub 2013 Oct 3. — View Citation

Hidalgo B, Hall T, Nielens H, Detrembleur C. Intertester agreement and validity of identifying lumbar pain provocative movement patterns using active and passive accessory movement tests. J Manipulative Physiol Ther. 2014 Feb;37(2):105-15. doi: 10.1016/j.jmpt.2013.09.006. Epub 2014 Jan 6. — View Citation

Kumar S, Beaton K, Hughes T. The effectiveness of massage therapy for the treatment of nonspecific low back pain: a systematic review of systematic reviews. Int J Gen Med. 2013 Sep 4;6:733-41. doi: 10.2147/IJGM.S50243. Review. — View Citation

Leysen P, Bombeke K, Remmen R. Osteopathic manual treatment and ultrasound therapy for chronic low back pain: an illustration of osteopathic semantic confusion. J Am Osteopath Assoc. 2013 Sep;113(9):660-1. doi: 10.7556/jaoa.2013.030. — View Citation

Licciardone JC. Osteopathic manual treatment and ultrasound therapy for chronic low back pain: an illustration of osteopathic semantic confusion. Author reply. J Am Osteopath Assoc. 2013 Sep;113(9):661-2. — View Citation

Muir JM. Chiropractic management of a patient with low back pain and Castellvi type II lumbosacral transitional vertebrae. J Chiropr Med. 2012 Dec;11(4):254-9. doi: 10.1016/j.jcm.2012.02.005. — View Citation

Rabin A, Shashua A, Pizem K, Dickstein R, Dar G. A clinical prediction rule to identify patients with low back pain who are likely to experience short-term success following lumbar stabilization exercises: a randomized controlled validation study. J Orthop Sports Phys Ther. 2014 Jan;44(1):6-B13. doi: 10.2519/jospt.2014.4888. Epub 2013 Nov 21. — View Citation

Zimney K, Louw A, Puentedura EJ. Use of Therapeutic Neuroscience Education to address psychosocial factors associated with acute low back pain: a case report. Physiother Theory Pract. 2014 Apr;30(3):202-9. doi: 10.3109/09593985.2013.856508. Epub 2013 Nov 19. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Roland Morris Disability Questionnaire (RMDQ)	This is a self-reported questionnaire consisting of 24 items reflecting limitations in different activities of daily living attributed to low back pain including walking, bending over, sitting, lying down, dressing, sleeping, self-care and daily activities.	At baseline, 12 weeks and 16 weeks	No
Secondary	Change from baseline in Oswestry Low Back Pain Disability Index (ODI)	The ODI has 10 items referring to activities of daily living that might be disrupted by low back pain. Each item is answered on a 6-point Likert scale ranging from "no problem at all" [0] to "not possible" [5]. The total score ranges from 0 to 50.	At baseline, 12 weeks and 16 weeks	No
Secondary	Change from baseline in Numerical Pain Rating Scale	A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) assesses the patients' current level of pain, and the worst and lowest level of pain experienced in the preceding 24 hours.	At baseline, 12 weeks and 16 weeks	No
Secondary	Change from baseline in Tampa Scale of Kinesiophobia	The Tampa Scale of Kinesiophobia (TSK) is a 17-item questionnaire developed to measure the fear of movement and (re)injury. Each item is scored on a four-point Likert scale ranging from "strongly disagree" [1] to "strongly agree" [4].	At baseline, 12 weeks and 16 weeks	No
Secondary	Change from baseline in Isometric endurance of trunk flexor muscles	The McQuade test measures the isometric resistance of abdominal muscles in seconds.	At baseline, 12 weeks and 16 weeks	No
Secondary	Change from baseline in Lumbar mobility in flexion	Lumbar mobility in flexion is determined by measuring the finger-to-floor distance with a tape.	At baseline, 12 weeks and 16 weeks	No