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Evaluating Chronic Pain Management Program

Primary Purpose

Chronic Musculoskeletal Pain

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Integrative Yoga Therapy
Sponsored by
Aarogyam UK
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Musculoskeletal Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults with chronic musculoskeletal pain, not accounted for by disease or underlying pathology
  • Self referred or referred willing to give informed consent

Exclusion Criteria:

  • Autoimmune disorder
  • Malignancies
  • Cognitively impairment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Support Group

    Arm Description

    This is the only group in the study consisting of patients with chronic musculoskeletal pain who are receiving the Integrative Yoga Therapy Program

    Outcomes

    Primary Outcome Measures

    Severity of pain and its impact on functioning: Brief Pain Inventory
    Brief Pain Inventory

    Secondary Outcome Measures

    General Quality of Life: Nottingham Health Profile
    Nottingham Health Profile
    Pain Service Satisfaction: The Pain Service Satisfaction Test (PSST)
    The Pain Service Satisfaction Test (PSST)

    Full Information

    First Posted
    March 16, 2020
    Last Updated
    March 17, 2020
    Sponsor
    Aarogyam UK
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04313309
    Brief Title
    Evaluating Chronic Pain Management Program
    Official Title
    Evaluating Outcomes of a Integrative Yoga Therapy for People With Chronic Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 15, 2020 (Anticipated)
    Primary Completion Date
    July 15, 2020 (Anticipated)
    Study Completion Date
    August 30, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Aarogyam UK

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This interventional study seeks to evaluate the overall outcomes of a novel, integrated yoga based intervention for people with chronic musculoskeletal pain and assess the experience of patient to the self care using yoga practices.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Musculoskeletal Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Support Group
    Arm Type
    Experimental
    Arm Description
    This is the only group in the study consisting of patients with chronic musculoskeletal pain who are receiving the Integrative Yoga Therapy Program
    Intervention Type
    Other
    Intervention Name(s)
    Integrative Yoga Therapy
    Intervention Description
    Individualised intervention developed, consists of a six one to one sessions with patients, followed by home self practiced sessions. The intervention includes yoga movements, yoga breathing, relaxation techniques, reasoning, and other techniques designed to enhance awareness and acceptance of the psychological factors underlying the chronic pain problem.
    Primary Outcome Measure Information:
    Title
    Severity of pain and its impact on functioning: Brief Pain Inventory
    Description
    Brief Pain Inventory
    Time Frame
    From baseline to 6-week post intervention
    Secondary Outcome Measure Information:
    Title
    General Quality of Life: Nottingham Health Profile
    Description
    Nottingham Health Profile
    Time Frame
    From baseline to 6-week post intervention
    Title
    Pain Service Satisfaction: The Pain Service Satisfaction Test (PSST)
    Description
    The Pain Service Satisfaction Test (PSST)
    Time Frame
    From baseline to 6-week post intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adults with chronic musculoskeletal pain, not accounted for by disease or underlying pathology Self referred or referred willing to give informed consent Exclusion Criteria: Autoimmune disorder Malignancies Cognitively impairment
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Usha Solanki
    Phone
    +44 7448307225
    Email
    ukaarogyam@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Neha Sharma, PhD
    Organizational Affiliation
    Aarogyam UK
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Jaydeep Joshi, BAMS
    Organizational Affiliation
    Aarogyam UK
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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