Clinical trial NCT02696057: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2016-03-02
Enrollment: 113
Sex: ALL
Minimum age (years): 23
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: changes in pain severity
timeFrame: change from baseline in pain severity at 6 weeks.
Secondary outcomes:
measure: Changes of functional status
timeFrame: change from baseline in back functions at 6 weeks.
measure: Changes in Quality of life
timeFrame: change form baseline in life quality levels at 6 weeks.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University, Health Sciences Faculty
Study officials:
affiliation: Hacettepe University
name: Aynur Demirel, PhD
role: STUDY_DIRECTOR
affiliation: Hacettepe University
name: Ozlem Ulger, Asc. Proff
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Seval Tamer, Msc
role: STUDY_DIRECTOR
affiliation: Hacettepe University
name: Muzeyyen Oz, PT
role: STUDY_DIRECTOR
References:
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