Spinal Manipulative Therapy Treatment Effect Modifiers in Individuals With Low Back Pain

Low Back Pain Clinical Trial

Official title:

Spinal Manipulative Therapy Treatment Effect Modifiers in Individuals With Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02476383
• Other study ID #: IRB201400928
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: June 14, 2019

Study information

• Verified date: June 2019
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study considers whether treatment effects in response to spinal manipulative therapy for individuals experiencing low back pain are dependent upon the context in which the intervention is provided. Half of the participants will receive spinal manipulative therapy with encouragement to interact with the provider and information to enhance expectations for the effectiveness of the intervention. The other half will receive spinal manipulative therapy with minimal interaction with the provider.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 14, 2019
• Est. primary completion date: June 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Currently experiencing low back pain defined as pain located below the 12th rib and above the inferior gluteal fold with or without corresponding leg pain;

• Low back pain symptom intensity rated as 4/10 or higher during the last 24 hour;

• Appropriate for conservative treatment for low back pain.

Exclusion Criteria:

• Non-English speaking;

• Systemic medical conditions know to affect sensation (e.g. diabetes);

• History of lumbar surgery or fracture within the past 6 months;

• Received spinal manipulative therapy for treatment of low back pain within past 6 months;

• Current or history of chronic pain condition other than low back pain

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Procedure:
• spinal manipulative therapy
refer to arm descriptions

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	numeric pain rating scale	0 to 100 with 0= no pain at all to 100= worst pain imaginable	Change in baseline at 2 weeks
Secondary	Oswestry Disability Index	0 to 100 with 0= no perceived disability to 100= greatest perceived disability	Change in baseline at 2 weeks
Secondary	Back Performance Scale	0 to 15 with lower scores indicating better performance	Change in baseline immediately following spinal manipulative therapy during day 1 and at 2 weeks
Secondary	Quantitative Sensory Testing	standardized thermal and pressure stimuli will be applied and participant will rate the pain associated with each using a 0= no pain to 100= worst pain imaginable numeric pain rating scale or a mechanical visual analog scale anchored with no pain and worst pain imaginable	change in baseline immediately following spinal manipulative therapy during day 1
Secondary	Patient Centered Outcome Questionnaire	Participants indicate their usual level, desired level, successful level, and expected level of pain, fatigue, emotional distress, and interference using a 0= none at all to 100= worst imaginable numeric rating scale	change in baseline immediately following spinal manipulative therapy during day 1
Secondary	Working alliance subscale of the Pain Rehabilitation Expectation Scale	Scored from 16= lesser therapeutic alliance to 64= greater therapeutic alliance	change in baseline immediately following spinal manipulative therapy during day 1
Secondary	North American Spine Society Lumbar Spine Outcome Assessment	Participants will answer 3 questions: 1) If you had to spend the rest of your life with the low back pain you have right now, how would you feel about it? Scored from 1= very dissatisfied to 5= very satisfied; 2) Would you have the same intervention you received in this study again for low back pain? Scored from 1=Definitely not to 5= definitely yes; 3) . How would you rate the overall results of the intervention you received in this study for low back pain? Scored from 1= Terrible to 6= Excellent	2 weeks
Secondary	Semi- structured qualitative interview seeking insight into answers on the working alliance subscale of the pain rehabilitation expectation scale	a brief semi- structured interview	2 weeks