Integrative Yoga Therapy for Patients With Chronic Pain and Psychological Distress

NCT04315805 | Unknown DMC

• 1 other identifier: AU07
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be a randomized wait list controlled trial studying the efficacy of an Integrative Yoga Therapy for patients with chronic pain and psychological distress. Individualised yoga program will consist of a 8-week guided self-help program. This study will primarily investigate whether an individually tailored yoga can be beneficial for patients suffering from chronic pain reducing pain, anxiety depression, while improving overall quality of life.

Conditions

Chronic Pain; Psychological Distress

Outcome Measures

Primary Outcomes (3)

• Pain Severity: Visual Analogue Scale

  Visual Analogue Scale ranging between 0-10 where 0 is no pain at all and 10 is worst pain

  From baseline to 8-week post intervention

• Pain Disability

  Change in pain disability using Pain Disability Index (PDI) with 7 item.Each item scores on 0-10 numeric rating scale in which 0 means no disability and 10 is maximum disability

  From baseline to 8-week post intervention

• Symptoms of depression and anxiety

  Hospital Anxiety Depression Scale with 14 item. Each item on the questionnaire is scored from 0-3 where higher score represents increased anxiety and depression levels

  From baseline to 8-week post intervention

Secondary Outcomes (3)

• Insomnia symptoms

  From baseline to 8-week post intervention

• Mental well-being

  From baseline to 8-week post intervention

• Self Efficacy: Pain Self-Efficacy Questionnaire (PSEQ)- 2 item scale

  From baseline to 8-week post intervention

Study Arms (2)

Integrative Yoga Therapy

EXPERIMENTAL

Integrative Yoga Therapy will be provided by yoga therapist once a week and participants will be encouraged to practice at home once or twice a day.

Other: Integrative Yoga Therapy

Wait-list Control

NO INTERVENTION

Participants in waiting list will serve as control group for the intervention period. After the ftherapy group has received treatment, the same program will be offered to participants in the wait-list control group.

Interventions

Integrative Yoga Therapy OTHER

Yoga therapy will be based on personalised care consisting of Yoga relaxing posture, strengthening exercise, Yoga breathing, meditative psychotherapy, sound and imagery yoga practices, relaxation, yoga diet and life style management.

Integrative Yoga Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Experienced pain for \> 3 months
• Experiences at least one type of psychological distress such as: depression, anxiety, insomnia or stress
• Willing to provide informed consent

You may not qualify if:

• Severe medical or psychiatric conditions
• Alcohol or substance abuse
• Active suicidality
• Terminal illness

Sponsors & Collaborators

• Aarogyam UK: lead

Study Sites (1)

Karyalaya

Leicester, Leicestershire, United Kingdom

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Neha Sharma, PhD

  Aarogyam UK

  PRINCIPAL INVESTIGATOR

• Jaydeep Joshi, BAMS

  Aarogyam UK

  STUDY DIRECTOR

Central Study Contacts

Usha Solanki

CONTACT

+447448307225; ukaarogyam@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2020
• First Posted: March 20, 2020
• Study Start: June 15, 2020
• Primary Completion: November 15, 2020
• Study Completion: December 15, 2020
• Last Updated: March 20, 2020

Record last verified: 2020-03

Locations

GB (1)