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

Not Applicable

Completed

• Conditions: Chronic Low Back Pain
• Interventions: Other: Exercise; Other: manual technics

• Registration Number: NCT02696057
• Lead Sponsor: Hacettepe University

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.

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Study First Submitted: 2016-02-24
• Study First Submitted QC: 2016-03-01
• Study First Posted: 2016-03-02
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-17
• Last Update Posted: 2018-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise	Exercise	Spinal stabilization exercises were applied all the patients in this group accompanied by physiotherapist.
Manual technics	manual technics	Manual technics was consisted of soft tissue technics, muscle energy technics, joint mobilization.

Primary Outcome Measures

Name	Time	Method
changes in pain severity	change from baseline in pain severity at 6 weeks.	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

Name	Time	Method
Changes in Quality of life	change form baseline in life quality levels at 6 weeks.	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.
Changes of functional status	change from baseline in back functions at 6 weeks.	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.

Trial Locations

Locations (1)

Hacettepe University, Health Sciences Faculty; 🇹🇷 Ankara, Turkey