Assessing the Impact of Exercise Based Intensive Interdisciplinary Pain Treatment (IIPT) on Endogenous Pain Modulation in Youth With Chronic Pain Syndromes

NCT05491499 | Completed

• 1 other identifier: P00043035
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

This work will answer two critical questions: 1) Does intensive interdisciplinary pain treatment (IIPT) involving aerobic exercise help normalize pain processing in youth with chronic pain syndromes and 2) Are aerobic fitness levels and the ability to modulate pain inter-related? Currently, medications are ineffective for improving pain and disability in youth with chronic pain syndromes and identifying non-pharmacologic treatments, such as IIPT, that help strengthen the nervous system's ability to modulate or turn pain signals down will improve outcomes and quality of life for youth suffering from chronic pain. This study will help determine whether exercise based IIPT leads to physiologic improvements in how pain is processed, specifically if youth with chronic pain can better turn pain down during the offset analgesia test after an exercise based IIPT treatment, and also help elucidate the link between a child's aerobic fitness and their ability to modulate pain.

Conditions

Chronic Pain Syndrome; Fibromyalgia; Chronic Headache Disorder; Functional Abdominal Pain Syndrome; Complex Regional Pain Syndromes

Outcome Measures

Primary Outcomes (1)

• Change in Offset Analgesia

  Percent reduction in pain following the small, 1º C stimulus offset.

  through study completion, an average of 4-6 weeks

Secondary Outcomes (3)

• Change in Control Test Response

  through study completion, an average of 4-6 weeks

• Change in Constant Test Response

  through study completion, an average of 4-6 weeks

• Change in Cardiovascular Endurance

  through study completion, an average of 4-6 weeks

Other Outcomes (4)

• Change in Anxiety

  through study completion, an average of 4-6 weeks

• Change in Depressive Symptoms

  through study completion, an average of 4-6 weeks

• Change in Pain Interference

  through study completion, an average of 4-6 weeks

Study Arms (1)

Youth with Chronic pain

We will recruit 38 youth with primary and secondary chronic pain syndromes\[29; 31\] ages 10-17 years who are admitted to the Mayo Family Pediatric Pain Rehabilitation Center at Boston Children's Hospital. This longitudinal cohort study will examine responses to the OA and Fitkids Treadmill tests at 2 timepoints: 1) within 5 days of IIPT admission and 2) within 1 week of IIPT discharge. Twelve participants will complete a 3rd visit within 5 days of the first study visit to examine OA test-retest reliability.

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Youth with all types of chronic pain syndromes (including but not limited to: headaches, abdominal pain, complex regional pain syndrome, amplified pain syndrome) admitted to the Mayo Family Pediatric Pain Rehabilitation Center for intensive interdisciplinary pain treatment.

You may qualify if:

• i) age 10-17 years
• ii) first test completed within 5 days of admission
• iii) established diagnosis of primary or secondary chronic pain
• iv) report of constant moderate pain (≥ 5/10 on a numeric rating scale of 0-10 points) for at least 3 months duration
• v) stable use of medications for at least one week prior to the study visit.

You may not qualify if:

• i) presence of allodynia in either upper extremity
• ii) a history of central nervous system, heart, kidney, liver and respiratory system diseases, and psychiatric disorders (e.g., bipolar, conversion, psychosis)
• iii) reported consumption of alcohol, cannabis or tobacco products
• iv) unable to read English or follow testing instructions
• v) intolerant to the thermal test stimulus, or vi) no pain reported at maximum stimulus (48ºC).

Sponsors & Collaborators

• Boston Children's Hospital: lead
• APTA Pediatrics: collaborator

Study Sites (1)

Boston Children's Hospital at Waltham

Waltham, Massachusetts, 02453, United States

Location

Related Publications (5)

• Shulman J, Zurakowski D, Keysor J, Jervis K, Sethna NF. Offset analgesia identifies impaired endogenous pain modulation in pediatric chronic pain disorders. Pain. 2020 Dec;161(12):2852-2859. doi: 10.1097/j.pain.0000000000001984.

  PMID: 32658151 BACKGROUND

• Kotte EM, de Groot JF, Bongers BC, Winkler AM, Takken T. Fitkids Treadmill Test: Age- and Sex-Related Normative Values in Dutch Children and Adolescents. Phys Ther. 2016 Nov;96(11):1764-1772. doi: 10.2522/ptj.20150399. Epub 2016 May 19.

  PMID: 27197825 BACKGROUND

• Grill JD, Coghill RC. Transient analgesia evoked by noxious stimulus offset. J Neurophysiol. 2002 Apr;87(4):2205-8. doi: 10.1152/jn.00730.2001.

  PMID: 11929939 BACKGROUND

• King S, Chambers CT, Huguet A, MacNevin RC, McGrath PJ, Parker L, MacDonald AJ. The epidemiology of chronic pain in children and adolescents revisited: a systematic review. Pain. 2011 Dec;152(12):2729-2738. doi: 10.1016/j.pain.2011.07.016.

  PMID: 22078064 BACKGROUND

• Hermans L, Calders P, Van Oosterwijck J, Verschelde E, Bertel E, Meeus M. An Overview of Offset Analgesia and the Comparison with Conditioned Pain Modulation: A Systematic Literature Review. Pain Physician. 2016 Jul;19(6):307-26.

  PMID: 27454261 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia; Complex Regional Pain Syndromes

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Autonomic Nervous System Diseases; Peripheral Nervous System Diseases

Study Officials

• Julie M Shulman, PT, PhD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapy Scientist

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: August 8, 2022
• Study Start: October 17, 2022
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: June 26, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)