Effect of Spinal Manipulation on Vulvar Pain

NCT04016467 | Terminated

• 1 other identifier: 6.7.2018
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine the effect of thoracic spine manipulation on vestibule pain as determined by sensory testing (q-tip and pressure algometry) in a group of women with provoked vestibulodynia (PVD). The objective is to compare the immediate effect of manipulation and sham manipulation on the results of sensory testing of the external vulva, or vestibule.

Conditions

Vulvodynia; Perineal Pain; Vulvar Pain

Keywords

Spinal Manipulation

Outcome Measures

Primary Outcomes (1)

• Change in Numeric Pain Rating Scale (NPRS) (0=none to 10=worst) report to cotton swab test in clock pattern

  Participant report on NPRS

  Pre and immediately post thoracic intervention. No longer term follow-up is planned.

Secondary Outcomes (1)

• Change in peak pressure algometer

  Pre and immediately post thoracic intervention. No longer term follow-up is planned

Study Arms (2)

Thoracic Manipulation (ThM)

EXPERIMENTAL

Will undergo spinal manipulation between pain assessment pre and post.

Other: Thoracic manipulation

Sham thoracic treatment (ThS)

SHAM COMPARATOR

Sham manipulation between pain assessment pre and post

Other: Sham thoracic treatment

Interventions

Thoracic manipulation OTHER

High velocity, small amplitude thrust treatment to spine that elicits a neurophysiologic response.

Thoracic Manipulation (ThM)

Sham thoracic treatment OTHER

Hand placement on thorax without thrust.

Sham thoracic treatment (ThS)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Provides written and dated informed consent to participate in the study.
• Is between the ages of 18-40 years.
• Reports pain in the pelvis and/or vestibule (area that is wiped after using the toilet) that has been present for ≥ 6 weeks.
• Has not had treatment for pelvic or vestibule pain in the 6 months prior to study participation.
• Is willing and able to comply with study protocol.
• Is healthy and free from disease, as determined by a health history questionnaire and screening exam.
• Agrees to abstain from alcohol consumption 24 hours prior to the study protocol.
• Reports a consistent regimen of pain medication use in the 6 weeks prior to the study protocol. This includes both prescription and over the counter medications.

You may not qualify if:

• Is currently pregnant, or attempting to become pregnant, as the intervention is contraindicated for this population.
• Fails the health history, spine screen; or does not demonstrate provoked vestibule pain with q-tip test.
• Has undergone any spine or pelvic girdle surgery in the 12 months prior to the study.
• Has ever had sling/mesh placement to the pelvic region.
• Has been diagnosed with osteopenia, osteoporosis, acute infection or arthritis flare, or other condition that could weaken the bony skeleton.
• Has ever had a thoracic spine fracture.
• Has had a change in any prescription or over-the-counter medications used for pain in the 6 weeks prior to the study.
• Any other condition or adverse event in which study investigator recommend removal from the study.

Sponsors & Collaborators

• University of Mary Hardin-Baylor: lead
• Integrity Rehab and Home Health: collaborator

Study Sites (1)

Integrity Rehab and Home Health

Copperas Cove, Texas, 76522, United States

Location

MeSH Terms

Conditions

Vulvodynia

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• PATRICIA NELSON, PT, ScD

  University of Mary Hardin-Baylor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomized intervention, blinding of pain measure to intervention PT, and blinding of intervention assignment pain assessment PT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Controlled clinical trial

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: July 11, 2019
• Study Start: May 10, 2019
• Primary Completion: October 15, 2020
• Study Completion: October 15, 2020
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)