Complementary and Integrative Pain Therapies and Functional Restoration (IMPPPORT) Trial)

Madigan Army Medical Center

Status: Completed

Conditions: Chronic Pain

Treatments: Other: non-medication, non-interventional therapies

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT04656340

DM140424 (Other Grant/Funding Number)

K24NR015340 (U.S. NIH Grant/Contract)

215050

Details and patient eligibility

About

This study aims to evaluate the benefit of a complementary and integrative health (CIH) pain management program when added to standard rehabilitative care (SC) compared to SC alone prior to an intensive functional restoration (FR) program in a population of active duty service members. In addition the study aims to identify factors that predict improvement in pain impact following treatment, and to determine the proportion of participants who experience clinically meaningful response.

SC included physical and occupational therapy. CIH included chiropractic, acupuncture, yoga and foam roller instruction. Both treatment groups also received education about pain psychology.

Participants were randomly assigned to a 3-week course of either SC alone or CIH combined with SC prior to a 3-week course of FR. Outcomes were collected at baseline, at end of stage 1, and post-FR. Outcomes included patient-reported and provider-determined measures.

Enrollment: 210 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Significant functional impairment due to pain, requiring modification of military duties.

• Physically able to participate in up to four hours of physical activity (strength, flexibility, endurance training) per day:

  1. Can stand up from and sit down on floor independently

  2. Can walk on treadmill for at least 6 minutes at 2.5 mile/hour pace or faster.

  3. Able to complete at least 2 of the following:

     1. Lift 20 lbs from floor to knuckle height
     2. Lift 20 lbs from floor to shoulder height
     3. Carry 20lbs at least 40 feet.

• Inadequate response to previous less intensive treatment

• Expresses motivation to take active role in regaining function

Exclusion criteria

• Major surgeries within past 6 months or planned within next 6 months
• Unstable psychological disorders
• Active substance use disorder
• High dose opioids of >120 milligrams of morphine equivalent doses (MED)/day

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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210 participants in 2 patient groups

Standard rehabilitative care (SC)

Active Comparator group

Description:

Twice weekly physical therapy, occupational therapy and pain psychoeducation

Treatment:

Other: non-medication, non-interventional therapies

Complementary and Integrative Health (CIH) therapies in addition to Standard rehabilitate care (SC)

Experimental group

Description:

Twice weekly chiropractic, acupuncture, yoga and foam roller instruction, in addition to SC

Treatment:

Other: non-medication, non-interventional therapies