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

July 17, 2018 updated by: Aynur Demirel, Hacettepe University

Bel-boyun ağrısı Nedeniyle başvuran Hastalarda farklı Fizyoterapi ve Manuel Terapi yöntemlerinin ağrı, Fonksiyon ve yaşam Kalitesi düzeyleri üzerin Etkisi

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

113

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06100
        • Hacettepe University, Health Sciences Faculty

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

23 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Manual technics
Manual technics was consisted of soft tissue technics, muscle energy technics, joint mobilization.
Other: manual technics
soft tissue technics, joint mobilization and muscle energy technics were applied three sessions per week, totally six week.
Active Comparator: Exercise
Spinal stabilization exercises were applied all the patients in this group accompanied by physiotherapist.
Other: Exercise
spinal stabilization exercise applied three sessions per week, totally six week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in pain severity
Time Frame: 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)
change from baseline in pain severity at 6 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of functional status
Time Frame: 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.
change from baseline in back functions at 6 weeks.
Changes in Quality of life
Time Frame: 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.
change form baseline in life quality levels at 6 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Investigators

  • Study Director: Aynur Demirel, PhD, Hacettepe University
  • Principal Investigator: Ozlem Ulger, Asc. Proff, Hacettepe University
  • Study Director: Seval Tamer, Msc, Hacettepe University
  • Study Director: Muzeyyen Oz, PT, Hacettepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

February 24, 2016

First Submitted That Met QC Criteria

March 1, 2016

First Posted (Estimate)

March 2, 2016

Study Record Updates

Last Update Posted (Actual)

July 18, 2018

Last Update Submitted That Met QC Criteria

July 17, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GO13/550

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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