Other Specified Pregnancy-Related ConditionsNCT03440073
Intervention for Pregnancy Related Pain
A study testing Mulligan Concept Intervention in people with Other Specified Pregnancy-Related Conditions, run by University of Idaho at 1 site in United States.
Trial summary
Women in rural communities receive less access to prenatal care, and experience slightly higher rates of complications during pregnancy. A very prevalent pregnancy related complication is Pregnancy Related Pelvic Girdle Pain (PPGP), effecting up to 76% of all pregnant women. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Other Specified Pregnancy-Related Conditions
- What is being tested?
- Mulligan Concept Intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2018to 30 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- reported pregnancy-related lumbopelvic pain
Who cannot join
- orthopaedic or neurological problems with walking
- prior surgery of the lumbar spine, pelvis, hip, or knee
- fracture
- known malignancy
- active inflammation in the lumbar spine or pelvis
- ankylosing spondylitis, Scheuermann's kyphosis, active polyarthritis, or severe osteoporosis
Show all 10Show fewer
- any pulmonary, cardiac, visual, auditory, or cognitive disorders
- any other multi/co-morbidities that limit the volunteers ability to complete a gait and sit-to-stand task
- does not receive consent from their maternity care provider
- pain is associated with something other than pregnancy, or is experienced outside of pregnancy prior to the first pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Integrated Sport Medicine and Rehabilitative Therapy Clinic
Moscow, Idaho, 83844
About this study
Official title: Mulligan Concept Intervention for Pregnancy Related Lumbo Pelvic Pain
Women in rural communities receive less access to prenatal care, and experience slightly higher rates of complications during pregnancy. A very prevalent pregnancy related complication is Pregnancy Related Pelvic Girdle Pain (PPGP), effecting up to 76% of all pregnant women. Historically, PPGP has been thought to originate from hormonal changes associated with pregnancy, but its cause is more likely due to loss of motor control and/or malpositioning of the pelvic bones. Despite growing interest and clinical awareness of the condition, treatment outcomes of PPGP are inconsistent and intervention studies are lacking. The goal of this proposal is to investigate a treatment modality with minimal risks and potential to be self-administered. The Mulligan Concept manual therapy technique aims to restore mechanical function of the lumbopelvic region and has yet to be measured in women with PPGP.
Read the detailed description
The long-term goal of this project is to develop an effective conservative treatment protocol that is easily accessible. The objective of this application is to determine if patients who are treated with Mulligan Concept manual therapy experience immediate and significant changes in pain and function. Our specific aims are: In women with PPGP, 1.) Determine if Mulligan Concept treatment produces immediate changes in pain and function, 2.) Determine whether the Mulligan Concept immediately restores or alters dysfunctional gait characteristics and pelvic girdle motor control, and 3.) Identify factors that mathematically predict treatment outcome. Our central hypothesis is that restoration of lumbopelvic positioning will result in immediate decrease in pain, increase in function, and improved gait mechanics.
Volunteers in the 20th-34th week of pregnancy, ages 20-45 years, who are experiencing PPGP will be screened and randomly assigned into treatment or placebo group based on age, weight, height, gestational week and number of pregnancies. All participants will undergo a standardized examination, complete patient reported outcome measures, and perform a walking gait, sit to stand, and active straight leg raise tasks. Kinematic, kinetic, and EMG recordings will be taken during performance of the tasks. The participants of the treatment group will receive a Mulligan Concept evaluation and treatment. Participants in the placebo group will receive only the Mulligan Concept evaluation. Participants will then repeat the same tasks and measures. The study will be conducted under a randomized triple blinded placebo trial design; the patients, researchers, and treating clinician will be blinded to group assignment. Independent sample t-tests will be conducted to determine if significant differences exist between the intervention and placebo group across several dependent variables. Regression analysis will be conducted in order to determine if intake factors mathematically predict treatment outcome.
- Being tested
- Mulligan Concept Intervention, Sham Mulligan Concept Treatment
- Keywords
- pregnancy, pain, pelvis, spine, manual therapy
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mulligan Concept InterventionOther
The concept is a manual therapy paradigm that includes a clinician applying joint mobilizations and having the patient perform concurrent active, pain free, movement.
Sham Mulligan Concept TreatmentOther
The treating clinician will ask the participant to perform the movements associated with the Mulligan Concept technique. The clinician will have her hands on the participant during the movement but will not apply any pressure or force.
| Study group | Role | What they receive |
|---|---|---|
| Mulligan Concept Intervention | Experimental | Mulligan Concept Intervention, including Mobilizations with Movement intervention is administered. Up to 30 minutes total treatment time. Receives: Other: Mulligan Concept Intervention |
| Sham Mulligan Concept Treatment | Sham comparator | Assessment procedures of the Mulligan Concept are followed, but no manual pressure is applied to the participant during treatment to provide a sham Mulligan Concept Treatment. Receives: Other: Sham Mulligan Concept Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-D motion Analysis- sit to stand
Kinematic data is collected during sit to stand task
Measured: Change from pre to post intervention (immediate, 30 minutes)
3-D Motion Analysis- gait
Kinematic data is collected during gait task
Measured: Change from pre to post intervention (immediate, 30 minutes)
3-D Motion Analysis- active straight leg raise
Kinematic data is collected during active straight leg raise task
Measured: Change from pre to post intervention (immediate, 30 minutes)
Secondary outcomes (7)
Electromyography- Sit to Stand
EMG data will be collected during the sit to stand task
Measured: Change from pre and post intervention (Immediate, 30 minutes)
Electromyography- Gait
EMG data will be collected during gait task
Measured: Change from pre and post intervention (Immediate, 30 minutes)
Electromyography- Straight Leg Raise
EMG data will be collected during the sit to stand, gait, and active single leg raise tasks.
Measured: Change from pre and post intervention (Immediate, 30 minutes)
Visual Analog Pain Scale
Patient Reported Outcome Measure, pain
Measured: Change from pre and post intervention (Immediate, 30 minutes)
Pelvic Girdle Questionnaire
Patient Reported Outcome Measure, region specific disablement
Measured: Change from pre and post intervention (Immediate, 30 minutes)
Assessment of Disablement Questionnaire
Patient Reported Outcome Measure, global disablement
Measured: Change from pre and post intervention (Immediate, 30 minutes)
Short Stress State Questionnaire
Patient Reported Outcome Measure, stress
Measured: Change from pre and post intervention (Immediate, 30 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study start10 Jan 2018
- Primary completion30 May 2018
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Other Specified Pregnancy-Related ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Idaho
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Lindsay Larkins, DAT, Principal investigator, University of Idaho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03440073
- Sponsor's protocol ID
- 17-042
- Other IDs
- 18-22QR-UI-PG76
- Status last verified
- Oct 2018
- First submitted
- 1 Feb 2018
- Last updated
- 23 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will only be known to the PI. Other researchers working on the project are blinded to IPD. The PI will maintain records on a secure computer, with secure server connection, located in a locked office. Data will be shared in aggregate without identifying information.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mulligan Concept Intervention for Pregnancy Related Lumbo Pelvic Pain
- ClinicalTrials.gov ID
- NCT03440073
- Acronym / sponsor ID
- 17-042
- Keywords
- pregnancy, pain, pelvis, spine, manual therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of IdahoUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 20 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Women in rural communities receive less access to prenatal care, and experience slightly higher rates of complications during pregnancy. A very prevalent pregnancy related complication is Pregnancy Related Pelvic Girdle Pain (PPGP), effecting up to 76% of all pregnant women. Historically, PPGP has been thought to originate from hormonal changes associated with pregnancy, but its cause is more likely due to loss of motor control and/or malpositioning of the pelvic bones. Despite growing interest and clinical awareness of the condition, treatment outcomes of PPGP are inconsistent and intervention studies are lacking. The goal of this proposal is to investigate a treatment modality with minimal risks and potential to be self-administered. The Mulligan Concept manual therapy technique aims to restore mechanical function of the lumbopelvic region and has yet to be measured in women with PPGP.
Detailed description
The long-term goal of this project is to develop an effective conservative treatment protocol that is easily accessible. The objective of this application is to determine if patients who are treated with Mulligan Concept manual therapy experience immediate and significant changes in pain and function. Our specific aims are: In women with PPGP, 1.) Determine if Mulligan Concept treatment produces immediate changes in pain and function, 2.) Determine whether the Mulligan Concept immediately restores or alters dysfunctional gait characteristics and pelvic girdle motor control, and 3.) Identify factors that mathematically predict treatment outcome. Our central hypothesis is that restoration of lumbopelvic positioning will result in immediate decrease in pain, increase in function, and improved gait mechanics.
Volunteers in the 20th-34th week of pregnancy, ages 20-45 years, who are experiencing PPGP will be screened and randomly assigned into treatment or placebo group based on age, weight, height, gestational week and number of pregnancies. All participants will undergo a standardized examination, complete patient reported outcome measures, and perform a walking gait, sit to stand, and active straight leg raise tasks. Kinematic, kinetic, and EMG recordings will be taken during performance of the tasks. The participants of the treatment group will receive a Mulligan Concept evaluation and treatment. Participants in the placebo group will receive only the Mulligan Concept evaluation. Participants will then repeat the same tasks and measures. The study will be conducted under a randomized triple blinded placebo trial design; the patients, researchers, and treating clinician will be blinded to group assignment. Independent sample t-tests will be conducted to determine if significant differences exist between the intervention and placebo group across several dependent variables. Regression analysis will be conducted in order to determine if intake factors mathematically predict treatment outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mulligan Concept Intervention | Experimental | Other: Mulligan Concept InterventionMulligan Concept Intervention, including Mobilizations with Movement intervention is administered. Up to 30 minutes total treatment time. |
| Sham Mulligan Concept Treatment | Sham comparator | Other: Sham Mulligan Concept TreatmentAssessment procedures of the Mulligan Concept are followed, but no manual pressure is applied to the participant during treatment to provide a sham Mulligan Concept Treatment. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- reported pregnancy-related lumbopelvic pain
Key exclusion criteria (10 listed)
- orthopaedic or neurological problems with walking
- prior surgery of the lumbar spine, pelvis, hip, or knee
- fracture
- known malignancy
- active inflammation in the lumbar spine or pelvis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mulligan Concept InterventionThe concept is a manual therapy paradigm that includes a clinician applying joint mobilizations and having the patient perform concurrent active, pain free, movement. | Other | Mulligan Concept Intervention |
| Sham Mulligan Concept TreatmentThe treating clinician will ask the participant to perform the movements associated with the Mulligan Concept technique. The clinician will have her hands on the participant during the movement but will not apply any pressure or force. | Other | Sham Mulligan Concept Treatment |
Primary outcome
3-D motion Analysis- sit to stand
Time frame: Change from pre to post intervention (immediate, 30 minutes)
Kinematic data is collected during sit to stand task
3-D Motion Analysis- gait
Time frame: Change from pre to post intervention (immediate, 30 minutes)
Kinematic data is collected during gait task
3-D Motion Analysis- active straight leg raise
Time frame: Change from pre to post intervention (immediate, 30 minutes)
Kinematic data is collected during active straight leg raise task
7 secondary outcomes
Electromyography- Sit to Stand
Time frame: Change from pre and post intervention (Immediate, 30 minutes)
Electromyography- Gait
Time frame: Change from pre and post intervention (Immediate, 30 minutes)
Electromyography- Straight Leg Raise
Time frame: Change from pre and post intervention (Immediate, 30 minutes)
Visual Analog Pain Scale
Time frame: Change from pre and post intervention (Immediate, 30 minutes)
Pelvic Girdle Questionnaire
Time frame: Change from pre and post intervention (Immediate, 30 minutes)
Assessment of Disablement Questionnaire
Time frame: Change from pre and post intervention (Immediate, 30 minutes)
Short Stress State Questionnaire
Time frame: Change from pre and post intervention (Immediate, 30 minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2018.
- Individual participant dataSharing planned: No. Individual participant data will only be known to the PI. Other researchers working on the project are blinded to IPD. The PI will maintain records on a secure computer, with secure server connection, located in a locked office. Data will be shared in aggregate without identifying information.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lindsay Larkins, DAT principal investigator
University of Idaho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mulligan Concept Intervention in people with Other Specified Pregnancy-Related Conditions, run by University of Idaho at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-D motion Analysis- sit to stand (time frame: Change from pre to post intervention (immediate, 30 minutes)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2018.