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

Chronic Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02696057
• Other study ID #: GO13/550
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: August 2015

Study information

• Verified date: July 2018
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 23 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Other:
• manual technics
soft tissue technics, joint mobilization and muscle energy technics were applied three sessions per week, totally six week.
• Exercise
spinal stabilization exercise applied three sessions per week, totally six week.

Locations

Country	Name	City	State
Turkey	Hacettepe University, Health Sciences Faculty	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

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. Review. — View 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: 10.118 — View 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. — View 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. Review. — View 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 — View 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. Review. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	change from baseline in pain severity at 6 weeks.
Secondary	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.	change from baseline in back functions at 6 weeks.
Secondary	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.	change form baseline in life quality levels at 6 weeks.