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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01314157
Other study ID # 1-Prado
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2011
Est. completion date November 30, 2011

Study information

Verified date July 2022
Source Federal University of São Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Isostretching is effective in treating chronic back pain to improve pain, quality of life and functional capacity.


Description:

Objective: This study investigated the influence of isostretching on patients with chronic low back pain. Methods: It was a randomized, controlled trial with concealed allocation, intention-to-treat analysis, and blind assessment. Fifty-four patients with chronic low back pain were randomized to an experimental group and a control group. The experimental group performed isostretching twice a week for 45 days, while the control group remained on the waiting list for physical therapy. Patients were submitted to evaluations at baseline, after 20 and 45 days of treatment with regard to pain, quality of life, functional capacity, and satisfaction. Results: The experimental group exhibited statistically significant improvements in comparison to the control group with regard to pain (p = .003), functional capacity (p = .026), patient satisfaction (p < .001), and quality of life as determined by the functional capacity (p = .012), physical aspects (p = .011) and pain (p = .006) subscales of the SF-36. The experimental group used a significantly lesser amount of pain medication than the control group (p = .03). Conclusion: Isostretching was effective in reducing pain and in improving function, patient satisfaction and some aspects of quality of life in patients with chronic low back pain.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date November 30, 2011
Est. primary completion date November 30, 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Individuals diagnosed with chronic low back pain with pain located between the last rib and the gluteal fold over 12 weeks; - Mechanical back pain that worsens with exertion and relieved by rest; - Pain between 3 and 8 cm measured by analog pain scale. Exclusion Criteria: - Subjects who presented pain root - Fibromyalgia - Severe scoliosis with abnormal alignment of the spine (Cobb angle> 40); Tumors in the column; Infiltration in the lumbar spine in the last three months; Previous surgery of the spine (patients return to work or process expulsion) - Have changed or initiated physical activity in the last three months - Body mass index greater than 30 kg/m2

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Isostretching
12 interventions (two times per week) for 45 minutes

Locations

Country Name City State
Brazil Erika Rosangela Alves Prado Maceió Alagoas

Sponsors (1)

Lead Sponsor Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of isostretching effects in patients with chronic low back pain Reviewed by analog pain scale. (VAS) 1 month
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