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Completed

NCT Number: NCT02696057

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

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.

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Key information

Conditions

Chronic Low Back Pain

Age range

23 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University, Health Sciences Faculty

Ankara, 06100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

manual technics

Other

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

Exercise

Other

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 2, 2016
Registry last updated
Jul 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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