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

NCT ID: NCT02696057

Last Updated: 2018-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-08-31

Brief Summary

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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.

Detailed Description

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113 patients participating in the study were divided into two groups. The patients in the physiotherapy group were instructed to perform special spinal stabilization exercises, while the patients in the manual therapy group were instructed to perform soft tissue mobilizations, muscle-energy techniques, joint mobilizations and/or manipulation methods depending on the nature of their lower back pain problems. Both groups were offered stabilization, strengthening, stretching, balance and exercise trainings as well as recommendations as to the daily life activities in line with the requirements of each individual. The severity of the pain suffered by the individuals was evaluated through a Visual Analog Scale. Oswestry Disability Index and Short Form-36 (SF-36) Scale were made respectively with respect to the functional condition and life quality. Assessments were repeated before and after the treatment.

Conditions

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Chronic Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Manual technics

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

Group Type ACTIVE_COMPARATOR

manual technics

Intervention Type OTHER

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

Exercise

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

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type OTHER

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

Interventions

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manual technics

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

Intervention Type OTHER

Exercise

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Clinical diagnosis of Rheumatoid Arthritis
* Clinical diagnosis of Alzheimer
* Clinical diagnosis of Peripheral Neuropathy
* Clinical diagnosis of Diabetes Mellitus
Minimum Eligible Age

23 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Aynur Demirel

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aynur Demirel, PhD

Role: STUDY_DIRECTOR

Hacettepe University

Ozlem Ulger, Asc. Proff

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Seval Tamer, Msc

Role: STUDY_DIRECTOR

Hacettepe University

Muzeyyen Oz, PT

Role: STUDY_DIRECTOR

Hacettepe University

Locations

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Hacettepe University, Health Sciences Faculty

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 22386046 (View on PubMed)

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.

Reference Type RESULT
PMID: 22072093 (View on PubMed)

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.

Reference Type RESULT
PMID: 15125860 (View on PubMed)

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.

Reference Type RESULT
PMID: 9112710 (View on PubMed)

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.

Reference Type RESULT
PMID: 25426289 (View on PubMed)

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.

Reference Type RESULT
PMID: 25816037 (View on PubMed)

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.

Reference Type RESULT
PMID: 15969885 (View on PubMed)

Other Identifiers

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GO13/550

Identifier Type: -

Identifier Source: org_study_id

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