Efficacy of Spinal Manipulation Therapy or Mindfulness-based Reduction Therapy on Patients With Chronic Low Back Pain

Chronic Low-back Pain Clinical Trial

Official title:

Evaluating Specific and Non-Specific Mechanisms in Two Distinct Complementary/Integrative Interventions for Chronic Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04744883
• Other study ID #: 17100503
• Status: Recruiting
• Phase: Early Phase 1
• Start date: August 10, 2020
• Est. completion date: July 31, 2024

Study information

• Verified date: May 2024
• Source: Rush University Medical Center
• Contact: John Burns, PhD
• Phone: 312-942-0379
• Email: john_burns[@]rush.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Chronic Pain Management (CPM) has increasingly utilized long-term opioid analgesic therapy, a change associated with increased opioid abuse (a greater exposure in vulnerable individuals), non-pain health consequences (hormone changes, falls), and a dramatic rise in opioid-related overdoses and deaths. Treatment strategies that minimize the need for chronic high-dose opioids are sorely needed. This project will aim to test what degree mindfulness therapy (MT) and spinal manipulation therapy (SMT) produce pre- to mid- to post-treatment changes in endogenous opioid (EO) function.

Description:

This project will determine whether enhancing endogenous opioids (via SMT or MT) permits achieving desired levels of analgesia with lower dosages of opioid analgesics, and fewer side effects and abuse-relevant drug effects. This X year project will test study hypotheses in a sample of 240 chronic low back pain patients. The study will have 2 key elements: 1) a randomized, controlled SMT or MT in chronic pain (CP) patients completing daily take home exercises and 2) laboratory evoked thermal pain protocols pre- and post- therapy, permitting the quantification of EO function and the examining of treatment-induced changes in EO function (placebo vs. naloxone).

The study will employ a mixed between/within-subjects design using double-blinded and placebo-controlled administration of the opioid antagonist (naloxone). The study will use a 8 week supervised MT or SMT manipulation with subjects randomly assigned to one of the groups. All participants will undergo 6 laboratory pain-induction sessions in total. 2 during the pre-treatment phase, 2 during the mid-treatment phase, and 2 post-treatment. The laboratory sessions are identical with the exception of one of the 2 mid-treatment laboratory sessions, where extra questionnaires are administered. Each laboratory session will be roughly 2-3 days apart and the first 2 laboratory sessions will occur prior to the randomization to the treatment condition.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. significant daily chronic pain intensity (=4 on a 10-point scale) and interference in performing daily activities due to pain (=3 on a 10-point scale) for at least 3 months

2. age 18-75 years (inclusive)

3. not using opioid analgesics on a daily basis or within 3 days of each laboratory session (confirmed via urine drug screen)

4. Intact cognitive status and ability to provide informed consent

5. ability to read and write in English sufficiently to understand and complete study questionnaires

Exclusion Criteria:

1. meet criteria for alcohol or substance abuse problems

2. meet criteria for past or present psychotic or bipolar disorders

3. inability to understand English well enough to complete questionnaires or participate in therapy

4. pain due to malignant conditions, rheumatoid arthritis, migraine or tension headache, complex regional pain syndrome, or fibromyalgia syndrome

5. lumbar surgery within past 6 months

6. pregnant

7. signs of nerve root compression (ie, positive straight-leg raise <45?).

8. liver diseases (e.g hepatitis or cirrhosis)

9. suicide ideation with intent

10. osteoporosis or bone demineralization

11. opioid-dependency

12. inability to hold breathe for 15 seconds

13. acute trauma to spine

14. long term use of corticosteroids

15. spinal cord stimulator or IT pump inserted in back

16. they have a BMI equal to or above 40

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain

Intervention

Other:
• Spinal Manipulation Therapy (SMT)
2 SMT techniques are administered each session, both of which are scripted interactions between the physical therapist (PT) providing the SMT and the subjects: 1) Participants will lie on the SMT table for 20 mins, while the PT sits approximately 6 ft away. As part of the script, the PT will review with subjects the inclusion/exclusion criteria ostensibly to ensure that nothing has changed. 2) The PT will perform the 2 SMT techniques during the next 20 mins. 3) Subjects will sit upright in a chair for the remaining 20 mins, while the PT sits approximately 6 feet away. The PT will review home exercises with participant.

Drug:
• Naloxone
In randomized order (crossover) across 2 laboratory sessions each approximately 3 days apart, participants will receive either 1) 2 doses of saline placebo (20ml each) or 2) weight-adjusted doses of Naloxone beginning with a dose of 0.11mg/kg followed by a weight-adjusted dose of 0.055 mg/kg
• Placebo
In randomized order (crossover) across 2 laboratory sessions each approximately 3 days apart, participants will receive either 1) 2 doses of saline placebo (20ml each) or 2) weight-adjusted doses of Naloxone beginning with a dose of 0.11mg/kg followed by a weight-adjusted dose of 0.055 mg/kg

Behavioral:
• Mindfulness Based Stress Reduction Therapy (MT)
Each MT session consists of (a) body scan meditation accompanied by awareness of breathing and other bodily sensations while in a lying position, (b) sitting meditation, focusing on awareness of breathing, bodily sensations, thoughts, and emotions (c) gentle movement exercises intended to develop awareness (mindfulness) during movement. In-session activities include suggestions for application of mindfulness as a method for responding positively to stress; dealing with the challenges of pain; and exercises focusing on the challenges and achievements patients experience in integrating mindfulness into their lives and the stressful situations they encounter. Additional discussion will focus on stress reactivity and they will be taught problem-solving skills to develop solutions to meet MT goals. Finally, patients will develop a written maintenance plan that includes a list of short- and long-term goals for applying mindfulness methods and a plan for dealing with possible setbacks.

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Rush University Medical Center	Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (112)

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* Note: There are 112 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference	Interference in daily activities attributed to chronic pain as reported by subjects. The PROMIS Pain Interference scale consists of 8 questions with a 5-point response scale ranging from Not at all - Very much. Participants are asked how much in the past 7 days everyday activities were affected by their pain. Higher scores indicate more pain interference in daily activities.	Baseline, after each weekly treatment session, 3- and 6-month follow-up (roughly 16 weeks)
Secondary	Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity (Short Form)	Intensity of chronic pain reported by subject. The PROMIS Pain Intensity scale consists of 3 questions with a 5-point response scale ranging from Had no pain - Very severe. Participants are asked how intense their pain has been in the past 7 days. Higher scores indicate more intense pain.	Baseline, after each weekly treatment session, 3- and 6-month follow-up (roughly 16 weeks)
Secondary	Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression	Degree of depressive symptoms reported by subject. The PROMIS Depression scale consists of 8 questions with a 5-point response scale ranging from Never - Always. Participants are asked how often they felt depressive emotions in the past 7 days. Higher scores indicate more depressive emotions.	Baseline, after each weekly treatment session, 3- and 6-month follow-up (roughly 16 weeks)
Secondary	Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (Short Form)	Amount of physical activity reported by subject. The PROMIS Physical Function scale consists of 27 questions with a 5-point response scale ranging from Without any difficulty - Unable to do. Participants are asked how much their pain affects their physical functioning. Higher scores indicate more inability to perform specific physical activities due to pain.	Baseline, after each weekly treatment session, 3- and 6-month follow-up (roughly 16 weeks)
Secondary	Change in Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance	Degree of sleep disturbance reported by subject. The PROMIS Sleep Disturbance scale consists of 8 questions with a 5-point response scale ranging from Not at all - Very much. Participants are asked how much in the past 7 days their pain interfered with their sleep. Higher scores indicate more sleep disruptions.	Baseline, after each weekly treatment session, 3- and 6-month follow-up (roughly 16 weeks)