NCT01488825

Brief Summary

The present study was designed to evaluate effect of yoga intervention on patients having frequent tension type headache.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

December 6, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 8, 2011

Completed
Last Updated

December 8, 2011

Status Verified

December 1, 2011

Enrollment Period

1.1 years

First QC Date

December 6, 2011

Last Update Submit

December 7, 2011

Conditions

Outcome Measures

Primary Outcomes (1)

  • Frequency of headache

    3 Months

Secondary Outcomes (6)

  • Duration of Headache

    3 months

  • Severity of headache

    3 Months

  • Analgesic consumption

    3 Months

  • Anxiety levels

    3 months

  • Depression

    3 months

  • +1 more secondary outcomes

Study Arms (2)

Wait-list control group

NO INTERVENTION

The wait-list control group received no intervention, or instruction and they were observed with their usual care for 12-weeks intervention period. Upon completion of the study, this group received 12 weeks of yoga intervention.

Yoga Intervention Group

EXPERIMENTAL

The yoga sessions developed specifically for study participant consisted of 12 weekly 60-minute designed to benefit in episodic tension type headache.

Behavioral: Yoga Therapy

Interventions

Yoga TherapyBEHAVIORAL

Therapeutically oriented style of yoga originated from Pancha Kosha philosophy of Vedanta was used throughout the trial. All the sessions emphasized on postures, breathing practices with the specific focus on relaxation, combination of chants and meditation. Once a week, Kunjal and Jalaneti (cleansing practices) were practiced in guidance of therapist. They all were instructed to eat light and rest on Kriya days.

Yoga Intervention Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • aged between 18 to 60 years
  • more than 5 but fewer than 15 headache episodes per month
  • headache intensity moderate to severe

You may not qualify if:

  • Patients on anti-psychotic, antidepressant or any prophylactic medication
  • pregnancy
  • Taking psychotherapy or any other alternative medicine
  • migraine headache more than 1 day a month
  • pain disorder, psychiatric or medical disorder requiring immediate treatment,
  • headache due to sinusitis, eyestrain, cervical spondylosis and posttraumatic headaches

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pain Clinic, NMP Medical Research Institute

Jaipur, Rajasthan, 302019, India

Location

MeSH Terms

Interventions

Yoga

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Neha SHARMA, PhD

    NMP Medical Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2011

First Posted

December 8, 2011

Study Start

January 1, 2005

Primary Completion

February 1, 2006

Study Completion

June 1, 2006

Last Updated

December 8, 2011

Record last verified: 2011-12

Locations