Integrative Yoga Therapy for Patients With Chronic Pain and Psychological Distress

Chronic Pain Clinical Trial

Official title:

Integrative Yoga Therapy for Patients With Chronic Pain and Psychological Distress

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04315805
• Other study ID #: AU07
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2020
• Est. completion date: December 15, 2020

Study information

• Verified date: March 2020
• Source: Aarogyam UK
• Contact: Usha Solanki
• Phone: +447448307225
• Email: ukaarogyam[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: December 15, 2020
• Est. primary completion date: November 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Severe medical or psychiatric conditions

• Alcohol or substance abuse

• Active suicidality

• Terminal illness

Related Conditions & MeSH terms

• Chronic Pain
• Psychological Distress

Intervention

Other:
• Integrative Yoga Therapy
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.

Locations

Country	Name	City	State
United Kingdom	Karyalaya	Leicester	Leicestershire

Sponsors (1)

Lead Sponsor	Collaborator
Aarogyam UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Insomnia symptoms	Insomnia Severity Index has seven questions each scores between 0-4. Higher score defines severity of clinical insomnia	From baseline to 8-week post intervention
Secondary	Mental well-being	The Short Warwick-Edinburgh Mental Wellbeing Scale; Minimum score: 7; maximum score: 35; higher score indicates greater level of wellbeing	From baseline to 8-week post intervention
Secondary	Self Efficacy: Pain Self-Efficacy Questionnaire (PSEQ)- 2 item scale	Pain Self-Efficacy Questionnaire (PSEQ)- 2 item scale	From baseline to 8-week post intervention