The Effect of Manual Therapy and Exercise in Patients With Chronic Low Back Pain
Primary Purpose
Chronic Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
manual technics
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Low Back Pain
Eligibility Criteria
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
Sites / Locations
- Hacettepe University, Health Sciences Faculty
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Manual technics
Exercise
Arm Description
Manual technics was consisted of soft tissue technics, muscle energy technics, joint mobilization.
Spinal stabilization exercises were applied all the patients in this group accompanied by physiotherapist.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Changes of functional status
Oswestry Disability Index: Various daily living activities are assessed by 10 questions each having a score of 0 to 5; points scored between 0 to 4 are recorded as no disability. Total score summed.
Changes in Quality of life
SF-36 Quality of Life: this scale consists 36 item which assess pain, functional-emotional status, sleep, general health, mental health, social status and energy levels.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02696057
Brief Title
The Effect of Manual Therapy and Exercise in Patients With Chronic Low Back Pain
Official Title
Bel-boyun ağrısı Nedeniyle başvuran Hastalarda farklı Fizyoterapi ve Manuel Terapi yöntemlerinin ağrı, Fonksiyon ve yaşam Kalitesi düzeyleri üzerin Etkisi
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
113 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Manual technics
Arm Type
Active Comparator
Arm Description
Manual technics was consisted of soft tissue technics, muscle energy technics, joint mobilization.
Arm Title
Exercise
Arm Type
Active Comparator
Arm Description
Spinal stabilization exercises were applied all the patients in this group accompanied by physiotherapist.
Intervention Type
Other
Intervention Name(s)
manual technics
Intervention Description
soft tissue technics, joint mobilization and muscle energy technics were applied three sessions per week, totally six week.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
spinal stabilization exercise applied three sessions per week, totally six week.
Primary Outcome Measure Information:
Title
changes in pain severity
Description
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)
Time Frame
change from baseline in pain severity at 6 weeks.
Secondary Outcome Measure Information:
Title
Changes of functional status
Description
Oswestry Disability Index: Various daily living activities are assessed by 10 questions each having a score of 0 to 5; points scored between 0 to 4 are recorded as no disability. Total score summed.
Time Frame
change from baseline in back functions at 6 weeks.
Title
Changes in Quality of life
Description
SF-36 Quality of Life: this scale consists 36 item which assess pain, functional-emotional status, sleep, general health, mental health, social status and energy levels.
Time Frame
change form baseline in life quality levels at 6 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aynur Demirel, PhD
Organizational Affiliation
Hacettepe University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ozlem Ulger, Asc. Proff
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Seval Tamer, Msc
Organizational Affiliation
Hacettepe University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Muzeyyen Oz, PT
Organizational Affiliation
Hacettepe University
Official's Role
Study Director
Facility Information:
Facility Name
Hacettepe University, Health Sciences Faculty
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22386046
Citation
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.
Results Reference
result
PubMed Identifier
22072093
Citation
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.
Results Reference
result
PubMed Identifier
15125860
Citation
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.
Results Reference
result
PubMed Identifier
9112710
Citation
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.
Results Reference
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PubMed Identifier
25426289
Citation
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.
Results Reference
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PubMed Identifier
25816037
Citation
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.
Results Reference
result
PubMed Identifier
15969885
Citation
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.
Results Reference
result
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The Effect of Manual Therapy and Exercise in Patients With Chronic Low Back Pain
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