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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02390336
Other study ID # NC-002
Secondary ID
Status Completed
Phase N/A
First received March 3, 2015
Last updated May 27, 2015
Start date March 2015
Est. completion date May 2015

Study information

Verified date May 2015
Source Escola Superior de Tecnologia da Saúde do Porto
Contact n/a
Is FDA regulated No
Health authority Portugal: Comissão de Ética da Escola Superior de Tecnologia da Saúde do Porto
Study type Interventional

Clinical Trial Summary

The concept of mobilization with movement, also referred to as a Mulligan mobilization, has not been studied in patients with hip osteoarthritis, subsisting questions about the possible effects in this population. The aim of this randomized controlled study is to compare the immediate effects of Mulligan mobilization with movement technique of pain, range of motion and physical function in patients with osteoarthritis of the hip.


Description:

Mulligan original theory for the efficacy of a Mobilization With Movement (MWM) is based on the concept associated with a "positional joint failure," which occurs due to injury and may lead to a change in the joint alignment and hence its biomechanical resulting in symptoms such as pain, joint stiffness or weakness. To perform the MWM technique it is required to implement many criteria. During execution is applied an maintained accessory glide in order to correct the positional fault, while a physiological movement or action that usually caused the pain is performed actively or passively. A key component for the MWM is that pain should always be reduced and / or eliminated during application.

All study participants will be submitted to an initial assessment protocol to determine the intensity of pain, the range of motion (ROM) in flexion and internal rotation of the hip and the collection of physical function parameters. After that, the intervention will be performed for each group, and then the re-evaluation will be carried out (final evaluation), pain intensity, ROM and physical function tests..


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date May 2015
Est. primary completion date May 2015
Accepts healthy volunteers No
Gender Both
Age group 50 Years and older
Eligibility Inclusion Criteria:

clinical criteria for the diagnosis of osteoarthritis of the hip (sensitivity 86% and specificity 75%) are:

- Medial hip rotation =15º, pain during medial rotation of the hip, morning fatigue in hip> 60 minutes and older than 50 years or

- Medial hip rotation <15, hip flexion = 115

Exclusion Criteria:

- Previous surgery or hip replacement or knee joint

- Another surgery in the lower extremities performed within 6 months, rheumatoid arthritis

- Uncontrolled hypertension or risk (moderate - high) of cardiac complications during exercise

- Disability unrelated to the hip or knee to prevent the safe participation during exercise, appliance of manual therapy or during march: vision problems affecting mobility, body weight equal to or greater than 155 kg, primary neurogenic disorder or significantly limitation of the lumbar level,advanced osteoporosis with manual therapy or other treatment technique that may interfere with the study

- With inability to understand the instructions and complete the study assessments

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Intervention

Other:
Real mobilization-with-movement (MWM)
For the MWM group, the investigator applied two techniques of mobilization with movement: one for flexion and one for medial rotation of the hip. With the hip in flexion, a stabilizing belt was placed on the medial side of the participant's thigh closest to the joint interline. The belt was placed around the pelvic region of the physical therapist, keeping a perpendicular direction to the participant's thigh. Maintaining a side slip, it was carried out a passive movement of 1) hip flexion (3x10) and 2) medial hip rotation (3x10) by the physiotherapist throughout painless amplitude.
Sham mobilization-with-movement (MWM)
In the sham group, the investigators conducted a technical simulation. The positioning of the patient and the physical therapist was the same, however, no accessory mobilization was performed with the help of the belt and did not performed repeated movements of passive flexion or medial rotation.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Natália Maria Oliveira Campelo

References & Publications (5)

Botha-Scheepers S, Riyazi N, Kroon HM, Scharloo M, Houwing-Duistermaat JJ, Slagboom E, Rosendaal FR, Breedveld FC, Kloppenburg M. Activity limitations in the lower extremities in patients with osteoarthritis: the modifying effects of illness perceptions and mental health. Osteoarthritis Cartilage. 2006 Nov;14(11):1104-10. Epub 2006 Jun 5. — View Citation

French HP, Cusack T, Brennan A, Caffrey A, Conroy R, Cuddy V, FitzGerald OM, Fitzpatrick M, Gilsenan C, Kane D, O'Connell PG, White B, McCarthy GM. Exercise and manual physiotherapy arthritis research trial (EMPART) for osteoarthritis of the hip: a multicenter randomized controlled trial. Arch Phys Med Rehabil. 2013 Feb;94(2):302-14. doi: 10.1016/j.apmr.2012.09.030. Epub 2012 Oct 16. Erratum in: Arch Phys Med Rehabil. 2013 Mar;94(3):600. Fitzpatrick, Martina [added]. — View Citation

Hando BR, Gill NW, Walker MJ, Garber M. Short- and long-term clinical outcomes following a standardized protocol of orthopedic manual physical therapy and exercise in individuals with osteoarthritis of the hip: a case series. J Man Manip Ther. 2012 Nov;20(4):192-200. doi: 10.1179/2042618612Y.0000000013. — View Citation

Hoeksma HL, Dekker J, Ronday HK, Breedveld FC, Van den Ende CH. Manual therapy in osteoarthritis of the hip: outcome in subgroups of patients. Rheumatology (Oxford). 2005 Apr;44(4):461-4. Epub 2005 Feb 3. — View Citation

Vicenzino B, Paungmali A, Teys P. Mulligan's mobilization-with-movement, positional faults and pain relief: current concepts from a critical review of literature. Man Ther. 2007 May;12(2):98-108. Epub 2006 Sep 7. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in the intensity of hip pain before and after the treatment Participants were asked to rate the intensity of their pain using an 11-point numerical pain rating scale (NPRS; 0: no pain; 10: maximum pain). participants will be assessed before and after intervention (interval: 15-20 minutes) Yes
Secondary Changes in the range of motion for the hip flexion before and after the treatment Assess ROM of the hip joint was used a universal goniometer BIOMET® (CAT.No.567330), it was considered a valid instrument to measure hip flexion. participants will be assessed before and after intervention (interval: 15-20 minutes) Yes
Secondary Changes in the range of motion for the medial hip rotation before and after the treatment Assess ROM of the hip joint was used a universal goniometer BIOMET® (CAT.No.567330), it was considered a valid instrument to measure medial hip rotation. participants will be assessed before and after intervention (interval: 15-20 minutes) Yes
Secondary Changes in the performing time of the physical function test timed up and go before and after the treatment The Timed "Up and Go" Test (TUG) is presented as a test that simulates some functional maneuvers of daily life, like, getting up, walking, running laps and siting down. participants will be assessed before and after intervention (interval: 15-20 minutes) Yes
Secondary Changes in the repetitions of the physical function test 30 seg sit to stand before and after the treatment The 30 sec Sit to Stand test or 30 sec Chair Stand Test (CST) is the functional evaluation of the strength of the lower limbs.Is to repeat the activity of sit and lift a maximum number of times during 30 seconds. participants will be assessed before and after intervention (interval: 15-20 minutes) Yes
Secondary Changes in the performing time of the physical function test 40 m. self placed walk before and after the treatment The test 40m Self Placed Walk (SPWT) consists is the functional assessment of physical ability of an individual coursing short distances (40 meters). participants will be assessed before and after intervention (interval: 15-20 minutes) Yes
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