The Effect of Manual Therapy and Exercise in Patients With Chronic Low Back Pain

NCT02696057 | Completed

• 1 other identifier: GO13/550
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

Brief Summary

Identification of the effects of spinal stabilization exercises and manual therapy methods on pain, function and quality of life in individuals with low back pain.

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (1)

• changes in pain severity

  Visual Analog Scale:It is used in assessing the severity of pain. The scale is 10 cm long, which is labeled differently on each end (0= no pain, 10= the most severe pain)

  change from baseline in pain severity at 6 weeks.

Secondary Outcomes (2)

• Changes of functional status

  change from baseline in back functions at 6 weeks.

• Changes in Quality of life

  change form baseline in life quality levels at 6 weeks.

Study Arms (2)

Manual technics

ACTIVE COMPARATOR

Manual technics was consisted of soft tissue technics, muscle energy technics, joint mobilization.

Other: manual technics

Exercise

ACTIVE COMPARATOR

Spinal stabilization exercises were applied all the patients in this group accompanied by physiotherapist.

Other: Exercise

Interventions

manual technics OTHER

soft tissue technics, joint mobilization and muscle energy technics were applied three sessions per week, totally six week.

Manual technics

Exercise OTHER

spinal stabilization exercise applied three sessions per week, totally six week.

Exercise

Eligibility Criteria

• Age: 23 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of chronic low back pain
• must have pain at least 3 or more according to Visual analog scale

You may not qualify if:

• Clinical diagnosis of Rheumatoid Arthritis
• Clinical diagnosis of Alzheimer
• Clinical diagnosis of Peripheral Neuropathy
• Clinical diagnosis of Diabetes Mellitus

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University, Health Sciences Faculty

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (7)

• Slater SL, Ford JJ, Richards MC, Taylor NF, Surkitt LD, Hahne AJ. The effectiveness of sub-group specific manual therapy for low back pain: a systematic review. Man Ther. 2012 Jun;17(3):201-12. doi: 10.1016/j.math.2012.01.006. Epub 2012 Mar 3.

  PMID: 22386046 RESULT

• Steiger F, Wirth B, de Bruin ED, Mannion AF. Is a positive clinical outcome after exercise therapy for chronic non-specific low back pain contingent upon a corresponding improvement in the targeted aspect(s) of performance? A systematic review. Eur Spine J. 2012 Apr;21(4):575-98. doi: 10.1007/s00586-011-2045-6. Epub 2011 Nov 10.

  PMID: 22072093 RESULT

• Bronfort G, Haas M, Evans RL, Bouter LM. Efficacy of spinal manipulation and mobilization for low back pain and neck pain: a systematic review and best evidence synthesis. Spine J. 2004 May-Jun;4(3):335-56. doi: 10.1016/j.spinee.2003.06.002.

  PMID: 15125860 RESULT

• Koes BW, Assendelft WJ, van der Heijden GJ, Bouter LM. Spinal manipulation for low back pain. An updated systematic review of randomized clinical trials. Spine (Phila Pa 1976). 1996 Dec 15;21(24):2860-71; discussion 2872-3. doi: 10.1097/00007632-199612150-00013.

  PMID: 9112710 RESULT

• Dougherty PE, Karuza J, Savino D, Katz P. Evaluation of a modified clinical prediction rule for use with spinal manipulative therapy in patients with chronic low back pain: a randomized clinical trial. Chiropr Man Therap. 2014 Nov 18;22(1):41. doi: 10.1186/s12998-014-0041-8. eCollection 2014.

  PMID: 25426289 RESULT

• Huang SL, Liu YX, Yuan GL, Zhang J, Yan HW. Characteristics of lumbar disc herniation with exacerbation of presentation due to spinal manipulative therapy. Medicine (Baltimore). 2015 Mar;94(12):e661. doi: 10.1097/MD.0000000000000661.

  PMID: 25816037 RESULT

• Kosinski MR, Schein JR, Vallow SM, Ascher S, Harte C, Shikiar R, Frank L, Margolis MK, Vorsanger G. An observational study of health-related quality of life and pain outcomes in chronic low back pain patients treated with fentanyl transdermal system. Curr Med Res Opin. 2005 Jun;21(6):849-62. doi: 10.1185/030079905X46377.

  PMID: 15969885 RESULT

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Aynur Demirel, PhD

  Hacettepe University

  STUDY DIRECTOR

• Ozlem Ulger, Asc. Proff

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Seval Tamer, Msc

  Hacettepe University

  STUDY DIRECTOR

• Muzeyyen Oz, PT

  Hacettepe University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: February 24, 2016
• First Posted: March 2, 2016
• Study Start: January 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: July 18, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)