Hip; AnomalyNCT04279756
Comparing the Effects of Mobilization With Movement (MWM), Self MWM, and Dynamic Stretching on Hip Internal Rotation)
A study testing Hip Mobilization with Movement, Self-Mobilization with Movement, Dynamic Stretch in people with Hip; Anomaly, run by University of South Carolina at 1 site in United States.
Trial summary
This study is looking to address the effectiveness of three different intervention on hip range of motion. There will be a therapist performed mobilization group, a self mobilization group, and a dynamic stretching group. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hip; Anomaly
- What is being tested?
- Hip Mobilization with Movement, Self-Mobilization with Movement, Dynamic Stretch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2019to 6 Apr 2020
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- <30 degrees hip internal rotation in at least 1 hip
Who cannot join
- Traumatic injury in last 6 months
- FAI
- fracture
- surgery within last 6 months
- positive FADDIR/FABER
- symptomatic OA
- RA
- Neurologic conditions
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina
Columbia, South Carolina, 29205
About this study
This study is looking to address the effectiveness of three different intervention on hip range of motion. There will be a therapist performed mobilization group, a self mobilization group, and a dynamic stretching group. Participants will be recruited from the University of South Carolina and randomly assigned between the three groups to have equal distribution and limit any biases. Participants will come in on two different days in order to receive the intervention on the first and have hip range of motion measured on both days. The investigators will be assessing if there is any significant difference between the three groups.
Read the detailed description
The goal of this study is to compare the efficacy of three clinical interventions intended to treat hip dysfunctions such as hip osteoarthritis. Physical therapists utilize mobilization with movement clinically to increase range of motion that has been limited by hip pathology. This study will compare mobilization with movement administered by a physical therapist, self-administered mobilization with movement, in which patients are instructed in the maneuver and then perform it at home, and dynamic stretching as instructed by a physical therapist. Efficacy will be judged through changes in hip internal rotation range of motion, a motion which is typically limited in patients with hip pathology.
The objectives of the study are to quantify the effects of two different modalities of hip mobilization with movement and dynamic stretching in terms of hip internal rotation increases, and to inform current physical therapy practice by filling gaps in the literature surrounding the therapeutic effects of hip mobilization with movement. This study is intended to better equip physical therapists to select the most appropriate evidence-based interventions, thereby increasing the quality of patient care.
- Conditions
- Hip; Anomaly
- Being tested
- Hip Mobilization with Movement, Self-Mobilization with Movement, Dynamic Stretch
- Keywords
- Hip mobilization on hip internal rotation
- Medical subject headings
- Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip Mobilization with Movement, Self-Mobilization with Movement, Dynamic StretchOther
Participants receive either a therapist performed mobilization with movement, a self-mobilization with movement, or a dynamic stretch.
| Study group | Role | What they receive |
|---|---|---|
| Mildly Impaired Group | Active comparator | This group is with participants with mildly impaired hip internal range of motion, from 25-30 degrees. Receives: Other: Hip Mobilization with Movement, Self-Mobilization with Movement, Dynamic Stretch |
| Moderately Impaired Group | Active comparator | This group is with participants with moderately impaired hip internal range of motion, from 20-24 degrees. Receives: Other: Hip Mobilization with Movement, Self-Mobilization with Movement, Dynamic Stretch |
| Severely Impaired Group | Active comparator | This group is with participants with severely impaired hip internal range of motion, less than 20 degrees. Receives: Other: Hip Mobilization with Movement, Self-Mobilization with Movement, Dynamic Stretch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degrees of change in hip internal range of motion measured using a bubble inclinometer
Degrees of change in hip internal range of motion will be measured before and after the intervention as well as a 24 hour follow up measurement to determine the duration of the increased range of motion before returning to baseline. All measurements will be taken using a bubble inclinometer which measures range of motion of a joint in degrees from 0-360.
Measured: Baseline, immediately post-intervention, 24 hours after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start17 Oct 2019
- Primary completion6 Apr 2020
- Study completion6 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Hip; AnomalyStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- 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
- Model description
- A parallel design, also called a parallel group study, compares two or more treatments. Participants are randomly assigned to either group, treatments are administered, and then the results are compared.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cathy Arnot, University of South Carolina
- Investigators
- Cathy Arnot, DPT, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04279756
- Sponsor's protocol ID
- Pro00089974
- Status last verified
- Feb 2021
- First submitted
- 17 Jan 2020
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data collected will be analyzed and interpreted only by the investigators listed for University of South Carolina and also investigators from Wingate University as they are also participating in the data collection.
Publications
Hughes PE, Hsu JC, Matava MJ. Hip Anatomy and Biomechanics in the Athlete. Sports Medicine and Arthroscopy Review. 2002;10(2):103-114. doi:10.1097/00132585-200210020-00002.
Moore KL, Dalley AF, Agur AMR. Clinically oriented anatomy. Philadelphia: Wolters Kluwer/Lippincott Williams & Wilkins Health; 2014.
Byrne DP, Mulhall KJ, Baker JF. Anatomy & Biomechanics of the Hip. The Open Sports Medicine Journal. 2010;4(1):51-57. doi:10.2174/1874387001004010051.
Simoneau GG, Hoenig KJ, Lepley JE, Papanek PE. Influence of hip position and gender on active hip internal and external rotation. J Orthop Sports Phys Ther. 1998 Sep;28(3):158-64. doi: 10.2519/jospt.1998.28.3.158.
PubMed 9742472Walsh R, Kinsella S. The effects of caudal mobilisation with movement (MWM) and caudal self-mobilisation with movement (SMWM) in relation to restricted internal rotation in the hip: A randomised control pilot study. Man Ther. 2016 Apr;22:9-15. doi: 10.1016/j.math.2016.01.007. Epub 2016 Jan 28.
PubMed 26995777Sadeghisani M, Manshadi FD, Kalantari KK, Rahimi A, Namnik N, Karimi MT, Oskouei AE. Correlation between Hip Rotation Range-of-Motion Impairment and Low Back Pain. A Literature Review. Ortop Traumatol Rehabil. 2015 Oct;17(5):455-62. doi: 10.5604/15093492.1186813.
PubMed 26751745Hoy D, Bain C, Williams G, March L, Brooks P, Blyth F, Woolf A, Vos T, Buchbinder R. A systematic review of the global prevalence of low back pain. Arthritis Rheum. 2012 Jun;64(6):2028-37. doi: 10.1002/art.34347. Epub 2012 Jan 9.
PubMed 22231424Van Dillen LR, Bloom NJ, Gombatto SP, Susco TM. Hip rotation range of motion in people with and without low back pain who participate in rotation-related sports. Phys Ther Sport. 2008 May;9(2):72-81. doi: 10.1016/j.ptsp.2008.01.002.
PubMed 19081817Almeida GP, de Souza VL, Sano SS, Saccol MF, Cohen M. Comparison of hip rotation range of motion in judo athletes with and without history of low back pain. Man Ther. 2012 Jun;17(3):231-5. doi: 10.1016/j.math.2012.01.004. Epub 2012 Jan 26.
PubMed 22281524Albertin ES, Miley EN, May J, Baker RT, Reordan D. The Effects of Hip Mobilizations on Patient Outcomes: A Critically Appraised Topic. J Sport Rehabil. 2019 May 1;28(4):390-394. doi: 10.1123/jsr.2016-0238. Epub 2018 Dec 17.
PubMed 29466073Steultjens MP, Dekker J, van Baar ME, Oostendorp RA, Bijlsma JW. Range of joint motion and disability in patients with osteoarthritis of the knee or hip. Rheumatology (Oxford). 2000 Sep;39(9):955-61. doi: 10.1093/rheumatology/39.9.955.
PubMed 10986299Dekker J, Boot B, van der Woude LH, Bijlsma JW. Pain and disability in osteoarthritis: a review of biobehavioral mechanisms. J Behav Med. 1992 Apr;15(2):189-214. doi: 10.1007/BF00848325.
PubMed 1533877Shakoor N, Lee KJ, Fogg LF, Block JA. Generalized vibratory deficits in osteoarthritis of the hip. Arthritis Rheum. 2008 Sep 15;59(9):1237-40. doi: 10.1002/art.24004.
PubMed 18759259Bennell KL, Hinman RS. A review of the clinical evidence for exercise in osteoarthritis of the hip and knee. J Sci Med Sport. 2011 Jan;14(1):4-9. doi: 10.1016/j.jsams.2010.08.002. Epub 2010 Sep 17.
PubMed 20851051Beselga C, Neto F, Alburquerque-Sendin F, Hall T, Oliveira-Campelo N. Immediate effects of hip mobilization with movement in patients with hip osteoarthritis: A randomised controlled trial. Man Ther. 2016 Apr;22:80-5. doi: 10.1016/j.math.2015.10.007. Epub 2015 Oct 31.
PubMed 26559319
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effects of Mobilization With Movement (MWM), Self MWM, and Dynamic Stretching on Hip Internal Rotation)
- ClinicalTrials.gov ID
- NCT04279756
- Acronym / sponsor ID
- Pro00089974
- Conditions
- Hip; Anomaly
- Keywords
- Hip mobilization on hip internal rotation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- 17 Oct 2019 (actual)
- Primary completion
- 6 Apr 2020 (actual)
- Study completion
- 6 Apr 2020 (actual)
- First posted
- 21 Feb 2020 (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.
This study is looking to address the effectiveness of three different intervention on hip range of motion. There will be a therapist performed mobilization group, a self mobilization group, and a dynamic stretching group. Participants will be recruited from the University of South Carolina and randomly assigned between the three groups to have equal distribution and limit any biases. Participants will come in on two different days in order to receive the intervention on the first and have hip range of motion measured on both days. The investigators will be assessing if there is any significant difference between the three groups.
Detailed description
The goal of this study is to compare the efficacy of three clinical interventions intended to treat hip dysfunctions such as hip osteoarthritis. Physical therapists utilize mobilization with movement clinically to increase range of motion that has been limited by hip pathology. This study will compare mobilization with movement administered by a physical therapist, self-administered mobilization with movement, in which patients are instructed in the maneuver and then perform it at home, and dynamic stretching as instructed by a physical therapist. Efficacy will be judged through changes in hip internal rotation range of motion, a motion which is typically limited in patients with hip pathology.
The objectives of the study are to quantify the effects of two different modalities of hip mobilization with movement and dynamic stretching in terms of hip internal rotation increases, and to inform current physical therapy practice by filling gaps in the literature surrounding the therapeutic effects of hip mobilization with movement. This study is intended to better equip physical therapists to select the most appropriate evidence-based interventions, thereby increasing the quality of patient care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A parallel design, also called a parallel group study, compares two or more treatments. Participants are randomly assigned to either group, treatments are administered, and then the results are compared.
| Arm | Type | Receives |
|---|---|---|
| Mildly Impaired Group | Active comparator | Other: Hip Mobilization with Movement, Self-Mobilization with Movement, Dynamic StretchThis group is with participants with mildly impaired hip internal range of motion, from 25-30 degrees. |
| Moderately Impaired Group | Active comparator | Other: Hip Mobilization with Movement, Self-Mobilization with Movement, Dynamic StretchThis group is with participants with moderately impaired hip internal range of motion, from 20-24 degrees. |
| Severely Impaired Group | Active comparator | Other: Hip Mobilization with Movement, Self-Mobilization with Movement, Dynamic StretchThis group is with participants with severely impaired hip internal range of motion, less than 20 degrees. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- <30 degrees hip internal rotation in at least 1 hip
Key exclusion criteria (8 listed)
- Traumatic injury in last 6 months
- FAI
- fracture
- surgery within last 6 months
- positive FADDIR/FABER
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 |
|---|---|---|
| Hip Mobilization with Movement, Self-Mobilization with Movement, Dynamic StretchParticipants receive either a therapist performed mobilization with movement, a self-mobilization with movement, or a dynamic stretch. | Other | Mildly Impaired Group, Moderately Impaired Group, Severely Impaired Group |
Primary outcome
Degrees of change in hip internal range of motion measured using a bubble inclinometer
Time frame: Baseline, immediately post-intervention, 24 hours after intervention
Degrees of change in hip internal range of motion will be measured before and after the intervention as well as a 24 hour follow up measurement to determine the duration of the increased range of motion before returning to baseline. All measurements will be taken using a bubble inclinometer which measures range of motion of a joint in degrees from 0-360.
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 21 Feb 2021.
- BackgroundHughes PE, Hsu JC, Matava MJ. Hip Anatomy and Biomechanics in the Athlete. Sports Medicine and Arthroscopy Review. 2002;10(2):103-114. doi:10.1097/00132585-200210020-00002.
- BackgroundMoore KL, Dalley AF, Agur AMR. Clinically oriented anatomy. Philadelphia: Wolters Kluwer/Lippincott Williams & Wilkins Health; 2014.
- BackgroundByrne DP, Mulhall KJ, Baker JF. Anatomy & Biomechanics of the Hip. The Open Sports Medicine Journal. 2010;4(1):51-57. doi:10.2174/1874387001004010051.
- Background: PubMed 9742472Simoneau GG, Hoenig KJ, Lepley JE, Papanek PE. Influence of hip position and gender on active hip internal and external rotation. J Orthop Sports Phys Ther. 1998 Sep;28(3):158-64. doi: 10.2519/jospt.1998.28.3.158.
- Background: PubMed 26995777Walsh R, Kinsella S. The effects of caudal mobilisation with movement (MWM) and caudal self-mobilisation with movement (SMWM) in relation to restricted internal rotation in the hip: A randomised control pilot study. Man Ther. 2016 Apr;22:9-15. doi: 10.1016/j.math.2016.01.007. Epub 2016 Jan 28.
- Background: PubMed 26751745Sadeghisani M, Manshadi FD, Kalantari KK, Rahimi A, Namnik N, Karimi MT, Oskouei AE. Correlation between Hip Rotation Range-of-Motion Impairment and Low Back Pain. A Literature Review. Ortop Traumatol Rehabil. 2015 Oct;17(5):455-62. doi: 10.5604/15093492.1186813.
- Background: PubMed 22231424Hoy D, Bain C, Williams G, March L, Brooks P, Blyth F, Woolf A, Vos T, Buchbinder R. A systematic review of the global prevalence of low back pain. Arthritis Rheum. 2012 Jun;64(6):2028-37. doi: 10.1002/art.34347. Epub 2012 Jan 9.
- Background: PubMed 19081817Van Dillen LR, Bloom NJ, Gombatto SP, Susco TM. Hip rotation range of motion in people with and without low back pain who participate in rotation-related sports. Phys Ther Sport. 2008 May;9(2):72-81. doi: 10.1016/j.ptsp.2008.01.002.
- Background: PubMed 22281524Almeida GP, de Souza VL, Sano SS, Saccol MF, Cohen M. Comparison of hip rotation range of motion in judo athletes with and without history of low back pain. Man Ther. 2012 Jun;17(3):231-5. doi: 10.1016/j.math.2012.01.004. Epub 2012 Jan 26.
- Background: PubMed 29466073Albertin ES, Miley EN, May J, Baker RT, Reordan D. The Effects of Hip Mobilizations on Patient Outcomes: A Critically Appraised Topic. J Sport Rehabil. 2019 May 1;28(4):390-394. doi: 10.1123/jsr.2016-0238. Epub 2018 Dec 17.
- Background: PubMed 10986299Steultjens MP, Dekker J, van Baar ME, Oostendorp RA, Bijlsma JW. Range of joint motion and disability in patients with osteoarthritis of the knee or hip. Rheumatology (Oxford). 2000 Sep;39(9):955-61. doi: 10.1093/rheumatology/39.9.955.
- Background: PubMed 1533877Dekker J, Boot B, van der Woude LH, Bijlsma JW. Pain and disability in osteoarthritis: a review of biobehavioral mechanisms. J Behav Med. 1992 Apr;15(2):189-214. doi: 10.1007/BF00848325.
- Individual participant dataSharing planned: No. All data collected will be analyzed and interpreted only by the investigators listed for University of South Carolina and also investigators from Wingate University as they are also participating in the data collection.
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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.
Cathy Arnot, DPT principal investigator
University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hip Mobilization with Movement, Self-Mobilization with Movement, Dynamic Stretch in people with Hip; Anomaly, run by University of South Carolina 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 8 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 21 Feb 2021. 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. 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?
Degrees of change in hip internal range of motion measured using a bubble inclinometer (time frame: Baseline, immediately post-intervention, 24 hours after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04279756, which also lists 27 linked publications.
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 21 Feb 2021.