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The Efficacy of Cryotherapy in Pregnancy Related Pelvic Girdle Pain

Primary Purpose

Pelvic Girdle Pain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cryotherapy
Education
Sponsored by
Loyola University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Girdle Pain

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • English speaking pregnant women presenting in their second or third trimester with acute posterior PGP (occurring within the last 3 months). Trimester will be determined from the date of last menses or ultrasound date.
  • Current VAS pain score between 2-4
  • Written informed consent

Exclusion Criteria:

  • Non-English speaking pregnant women <18 or >50 years old
  • Women presenting with low back pain, or posterior pelvic pain in the first trimester (<13 weeks gestation).
  • Women with acute low back pain in 2nd and 3rd trimester
  • Women with anterior pelvic girdle pain (pubic symphysis) alone
  • Chronic low back pain (current or past history, defined as > 6 weeks of low back pain)
  • History of lumbar or pelvic fracture; degenerative disc disease; neoplasm; inflammatory disease; active urogenital infection or active gastrointestinal illness; previous surgery of the lumbar spine, pelvic girdle, hip joint or femur
  • History or signs of radiculopathy or other systemic neurologic disease
  • Narcotic medication use

Sites / Locations

  • Loyola University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

cryotherapy + education

education alone

Arm Description

intervention group will receive a 20-minute topical cryotherapy treatment (using Medline Deluxe Cold Pack) The education portion will consist of a handout that will be provided to each patient describing specific exercises. These exercises include descriptive information along with pictures on ways to improve posture and protect the lower back in pregnancy good posture

The education portion will consist of a handout that will be provided to each patient describing specific exercises. These exercises include descriptive information along with pictures on ways to improve posture and protect the lower back in pregnancy good posture

Outcomes

Primary Outcome Measures

Change in pelvic girdle pain using the Numeric Pain Rating Scale
The change in the Numeric Pain Rating Scale (NPRS) from baseline to day 6 (i.e., the delta value of NPRS) will be compared between the two groups. NPRS scores range from 0 (no pain) to 10 (worst possible pain).
Change in pelvic girdle pain using the Pelvic Girdle Questionnaire
The change in the the Pelvic Girdle Questionnaire (PGQ) from baseline to day 6 (i.e., the delta value of PGQ) will be compared between the two groups. The PGQ measures problems with carrying out daily activities and ranges from 0 (no problem at all) to 100 (experiences problems to a large extent).

Secondary Outcome Measures

Full Information

First Posted
June 16, 2020
Last Updated
March 29, 2022
Sponsor
Loyola University
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1. Study Identification

Unique Protocol Identification Number
NCT04469192
Brief Title
The Efficacy of Cryotherapy in Pregnancy Related Pelvic Girdle Pain
Official Title
The Efficacy of Cryotherapy in Pregnancy Related Pelvic Girdle Pain
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loyola University

4. Oversight

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

5. Study Description

Brief Summary
The findings from this project may result in pain reduction and improved mobility in pregnant women with pelvic girdle pain in their second and third trimester.
Detailed Description
The primary objective of this unblinded randomized controlled trial is to determine whether superficial cryotherapy results in improved Numeric Pain Rating Scale (NPRS) scores among pregnant women with posterior pelvic girdle pain. The investigators hypothesize that superficial cryotherapy, in addition to receipt of an educational pamphlet, will result in improved NPRS scores compared to receipt of an educational pamphlet alone. This study will include English-speaking pregnant women presenting to Loyola University Medical Center obstetrics or rehabilitation clinics in their second or third trimester with posterior pelvic girdle pain, defined as an NPRS score > 2 onset within the past 3 months and pain experienced between the posterior iliac crest and the gluteal fold, particularly in the vicinity of the sacroiliac joints (SIJ). The pain may radiate in the posterior thigh and can also occur in conjunction with/or separately in the [pubic] symphysis. NPRS scores will be measured as a continuous, numerical integer ranging from a value of 0 (No pain) to a value of 10 (Worst possible pain).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Girdle Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Study participants will then be randomized to cryotherapy + education vs. education alone. The education portion will consist of a handout that will be provided to each patient describing specific exercises. These exercises include descriptive information along with pictures on ways to improve posture and protect the lower back in pregnancy good posture. Those randomized to the intervention group will receive a 20-minute topical cryotherapy treatment (using Medline Deluxe Cold Pack) at this initial visit where they will be monitored for any adverse response as well as for any immediate change to the NPRS and PGQ. The participant will place the icepack over the low back region and the sacrum if the pain is bilateral. If the pain is unilateral will place the icepack over just that side.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
cryotherapy + education
Arm Type
Experimental
Arm Description
intervention group will receive a 20-minute topical cryotherapy treatment (using Medline Deluxe Cold Pack) The education portion will consist of a handout that will be provided to each patient describing specific exercises. These exercises include descriptive information along with pictures on ways to improve posture and protect the lower back in pregnancy good posture
Arm Title
education alone
Arm Type
Active Comparator
Arm Description
The education portion will consist of a handout that will be provided to each patient describing specific exercises. These exercises include descriptive information along with pictures on ways to improve posture and protect the lower back in pregnancy good posture
Intervention Type
Other
Intervention Name(s)
Cryotherapy
Intervention Description
intervention group will receive a 20-minute topical cryotherapy treatment (using Medline Deluxe Cold Pack) The education portion will consist of a handout that will be provided to each patient describing specific exercises. These exercises include descriptive information along with pictures on ways to improve posture and protect the lower back in pregnancy good posture
Intervention Type
Other
Intervention Name(s)
Education
Intervention Description
The education portion will consist of a handout that will be provided to each patient describing specific exercises. These exercises include descriptive information along with pictures on ways to improve posture and protect the lower back in pregnancy good posture
Primary Outcome Measure Information:
Title
Change in pelvic girdle pain using the Numeric Pain Rating Scale
Description
The change in the Numeric Pain Rating Scale (NPRS) from baseline to day 6 (i.e., the delta value of NPRS) will be compared between the two groups. NPRS scores range from 0 (no pain) to 10 (worst possible pain).
Time Frame
On day 6
Title
Change in pelvic girdle pain using the Pelvic Girdle Questionnaire
Description
The change in the the Pelvic Girdle Questionnaire (PGQ) from baseline to day 6 (i.e., the delta value of PGQ) will be compared between the two groups. The PGQ measures problems with carrying out daily activities and ranges from 0 (no problem at all) to 100 (experiences problems to a large extent).
Time Frame
On day 6

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: English speaking pregnant women presenting in their second or third trimester with acute posterior PGP (occurring within the last 3 months). Trimester will be determined from the date of last menses or ultrasound date. Current VAS pain score between 2-4 Written informed consent Exclusion Criteria: Non-English speaking pregnant women <18 or >50 years old Women presenting with low back pain, or posterior pelvic pain in the first trimester (<13 weeks gestation). Women with acute low back pain in 2nd and 3rd trimester Women with anterior pelvic girdle pain (pubic symphysis) alone Chronic low back pain (current or past history, defined as > 6 weeks of low back pain) History of lumbar or pelvic fracture; degenerative disc disease; neoplasm; inflammatory disease; active urogenital infection or active gastrointestinal illness; previous surgery of the lumbar spine, pelvic girdle, hip joint or femur History or signs of radiculopathy or other systemic neurologic disease Narcotic medication use
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mary Tulke, RN
Phone
708-476-2186
Email
mtulke@luc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colleen Fitzgwerald, MD
Organizational Affiliation
Loyola Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary J Tulke, R.N.
Phone
708-216-2067
Email
mtulke@luc.edu
First Name & Middle Initial & Last Name & Degree
Colleen Fitzgerald, M.D.

12. IPD Sharing Statement

Learn more about this trial

The Efficacy of Cryotherapy in Pregnancy Related Pelvic Girdle Pain

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