Condition category
Musculoskeletal Diseases
Date applied
19/05/2011
Date assigned
26/05/2011
Last edited
31/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 3

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jorge Hugo Villafañe

ORCID ID

Contact details

Via C. colombo 2/9
piossasco
10045
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Hypoalgesic effects of glide mobilization on elderly patients with secondary thumb carpometacarpal osteoarthritis - a randomized, controlled trial

Acronym

Study hypothesis

The aim of this study was to determine whether specific mobilization of posterior-anterior gliding of the trapeziometacarpal joint (TMJ) decreases mechanical hyperalgesia and increase the strength of the tip pinch and tripod pinch in patients with secondary carpometacarpal osteoarthritis in the dominant hand

Ethics approval

Local Health Authority, Collegno, Italy (Residenze Sanitarie Assistenziali Azienda Sanitaria Locale 3 (A.S.L 3), Collegno Italy) ref: 93571/c

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Thumb carpometacarpal osteoarthritis (TCOA)

Intervention

1. Glide mobilization
1.1. We performed a glide mobilization also known as mobilization of posterior-anterior gliding of the TMJ, taking into account the convex/concave rule
1.2. The direction of decreased joint gliding in a hypomobile joint and thus appropriate treatment can be deduced by this rule
1.3. Movement of a concave joint partner the glide occurs in the same direction
1.4. The form of the joint surface has been considered to induce its gliding movement: a female (concave) joint surface glides in the same direction as the bone movement, while a male (convex) surface is gliding in the opposite direction of the bone movement
1.5. The subject is seated with his arm in the anatomic position, the elbow at 90° flexion, and the forearm and hand with the cubital face downwards and the dorsal face against the body of the physiotherapist
1.7. The physiotherapist takes the right thumb metacarpal bone of the subject with his right thumb and index finger and makes a specific glide mobilization of posterior-anterior gliding of the TMJ for 3 minutes with a 1 minute pause; the action is repeated three times
1.8. The physiotherapist glides the first metacarpal bone in a posterior-anterior orientation
1.9. In the posterior-anterior gliding movement of the first metacarpal bone, the head and body must slide in the same way because the articular surface of the trapezium is convex and the surface of the first metacarpal bone is concave
1.10. The gliding movement respects the rule of convexity-concavity of the joint
2. Sham group
2.1. Participants in the sham group attended the same number of sessions as did those in the glide mobilization group, but they received applying intermittent ultrasound with non-therapeutic actions for 10 minutes on in the hypothenar area of the dominant hand
2.2. Gel was used as required

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Pain Measurement
1.1. We measured the pressure pain threshold (PPT) by using a mechanical pressure algometer (Wagner Instruments, Greenwich, CT, USA) with a 1cm2 rubber-tipped plunger mounted on a force transducer
1.2. The PPT is defined as the minimum amount of pressure that results in the sense of pressure changing to pain
1.3. The mean of three measurements (intra-examiner reliability) was calculated and used for the main analysis
1.4. The range of values of the pressure algometer was 0 to 10 kg, with a minimal sensibility of 0.1 kg
1.5. For these specific cases, the algometry has higher reliability (Intra-class correlation coefficient [ICC]=0.91, Interval confidence [IC] del 95%: 0.82-0.97) for PPT measurement in older patients
1.6. In addition, previous studies have reported an intra-examiner reliability for this procedure ranging from 0.6 to 0.97, and the inter-examiner reliability ranged from 0.4 to 0.98
1.7. PPT measurements were collected at both thecarpometacarpal (CMC) joint at the bottom of the anatomical snuffbox and tubercle of the scaphoid bone
2. Strength measurements
3. Pinch strength
3.1 The pinch strength was measured by a mechanical pinch gauge (Baseline, NY, USA) while the patient was in the sitting position with the shoulder adducted and neutrally rotated and the elbow flexed at 90°
3.2. Two different measurements were taken: first, the tip pinch between the index finger and thumb and, then, the tripod pinch between the index and medial fingers and the thumb 3.3. The reliability of this procedure to measure the pinch strength has been found to be on the order of 0.93
4. Grip strength measurements
4.1. Grip strength measurements were taken with a grip dynamometer (Baseline, NY, USA) while the patient was also in the sitting position, which has a precision and reliability of ± 3% for grip strength measurements
4.2. The reliability of the measurements was expressed by ICC between 0.82 and 0.97 for grip strength measurements
5. Pinch strength
5.1. The pinch strength was measured by a mechanical pinch gauge (Baseline, NY, USA) while the patient was in the sitting position with the shoulder adducted and neutrally rotated and the elbow flexed at 90°
5.2. Two different measurements were taken: first, the tip pinch between the index finger and thumb and, then, the tripod pinch between the index and medial fingers and the thumb 5.3. The reliability of this procedure to measure the pinch strength has been found to be on the order of 0.93

Secondary outcome measures

No secondary outcome measures

Overall trial start date

20/12/2009

Overall trial end date

30/09/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients who used the dominant hand systematically such as ex-factory workers and home workers
2. Diagnosed with secondary thumb carpometacarpal osteoarthritis (TCOA) in the dominant hand by X-ray detection of stage III and IV according to the Eaton-Littler-Burton Classification
3. The population of the study was 70-90 years old and were male and females

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

28

Participant exclusion criteria

1. Patients with a medical history of carpal tunnel syndrome, arthritis, surgical interventions on CMC joint, or D’Quervain’s tenosynovitis
2. Patients presenting degenerative or non-degenerative neurological conditions in which pain perception was altered

Recruitment start date

20/12/2009

Recruitment end date

30/09/2010

Locations

Countries of recruitment

Italy

Trial participating centre

Via C. colombo 2/9
piossasco
10045
Italy

Sponsor information

Organisation

Azienda Sanitaria Locale (ASL) 3 (Italy)

Sponsor details

c/o Jorge Hugo Villafane
Via C. colombo 2/9
Collegno
10093
Italy
Piossasco
10045
Italy

Sponsor type

Hospital/treatment centre

Website

http://www.villafane.it>):

Funders

Funder type

University/education

Funder name

Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Rey Juan Carlos University, Alcorcón, Spain

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Azienda Sanitaria Locale (ASL) 3, Collegno, Italy

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes