Comparison of Different Massage Techniques Plus Conservative Applications in Low Back Pain

NCT02714803 | Completed Phase 2

• 1 other identifier: 2015-11/33
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare of different massage techniques plus conservative aplications in low back pain treatment.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Change in low back pain intensity as measured by Visual Analog Scale

  Change from baseline low back pain intensity at 2 weeks

Secondary Outcomes (3)

• Change in quality of life as assessed by Short Form-36

  Change from baseline quality of life at 2 weeks

• Change in functional statue as assessed by Oswestry Disability Index

  Change from baseline functional statue at 2 weeks

• Change in psychologic statue as assessed by Hospital Anxiety and Depression Scale

  Change from baseline psychologic statue at 2 weeks

Study Arms (3)

Connective tissue massage group

EXPERIMENTAL

Connective tissue massage plus conservative applications including superficial thermal, electrotherapy and home exercise program were applied

Behavioral: "Connective tissue massage" and "Conservative applications"

Classic massage group

ACTIVE COMPARATOR

Classic massage plus conservative applications including superficial thermal, electrotherapy and home exercise program were applied

Behavioral: "Classic massage group" and "Conservative applications"

Sham massage group

SHAM COMPARATOR

Sham massage plus conservative applications including superficial thermal, electrotherapy and home exercise program were applied

Behavioral: "Sham massage group" and "Conservative applications"

Interventions

"Connective tissue massage" and "Conservative applications" BEHAVIORAL

Connective tissue massage and conservative aplications were applied 5 days per week for a total of 10 sessions for 2 weeks.

Connective tissue massage group

"Classic massage group" and "Conservative applications" BEHAVIORAL

Classic massage and conservative aplications were applied 5 days per week for a total of 10 sessions for 2 weeks.

Classic massage group

"Sham massage group" and "Conservative applications" BEHAVIORAL

Sham massage and conservative aplications were applied 5 days per week for a total of 10 sessions for 2 weeks.

Sham massage group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having non specific low back pain without any relevant ongoing pathologies such as disc prolapse, spondylolisthesis, fractures, tumor, osteoporosis, infection
• Willing to participate

You may not qualify if:

• Spinal surgery in the past 6 months or having to undergo surgery or invasive examinations during the study;
• neurological disease;
• psychiatric disease;
• serious chronic disease that could interfere with the outcomes (e.g., cardiovascular disease, epilepsy, rheumatoid arthritis),
• pregnant during the study

Sponsors & Collaborators

• Ataturk Training and Research Hospital: lead

Study Sites (1)

Ataturk Training and Research Hospital

Ankara, Cankaya, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 12, 2016
• First Posted: March 22, 2016
• Study Start: March 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: October 1, 2015
• Last Updated: March 22, 2016

Record last verified: 2016-03

Locations

TU (1)