Condition category
Musculoskeletal Diseases
Date applied
15/05/2011
Date assigned
26/05/2011
Last edited
31/08/2012
Prospective/Retrospective
Prospectively 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 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 and motor effects of Kaltenborn mobilization on elderly patients with secondary thumb carpometacarpal osteoarthritis: a randomized, controlled trial

Acronym

Study hypothesis

The thumb assumes 50% of the hand function, and the carpometacarpal (CMC) joint is the most important of its osteoarticular complex. Carpometacarpal osteoarthritis (CMC OA) is a degenerative alteration of the CMC OA that is characterized by abrasion, progressive deterioration of the joint surfaces and new bone formation at the site of deterioration. The impact of this pathology is the functional deficit that it causes in its most severe form. CMC OA is a process that affects mainly postmenopausal women, and at present, it is considered the upper limb osteoarthritis that causes of most surgical treatments.

The aim of this study was to determine whether specific Kaltenborn mobilization of posterior-anterior gliding with distraction of the carpometacarpal (CMC) joint 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) 12/10/2008

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Carpometacarpal osteoarthritis

Intervention

Kaltenborn’s mobilization technique:
In brief, Kaltenborn described these mechanics in terms of the convex-concave rule. The direction of decreased joint gliding in a hypomobile joint and thus the appropriate treatment can be deduced by this rule. With movement of a concave joint partner, the glide occurs in the same direction. The form of the joint surface has been considered to induce its gliding/sliding movement; a female (concave) joint surface glides in the same direction as the bone movement while a male (convex) surface glides in the opposite direction of the bone movement. Traction is the technique that distracts one articular surface perpendicular to the other, and the glide technique describes the translational gliding of one articular surface parallel to the other.

1. We used the specific Kaltenborn mobilization of posterior-anterior gliding with distraction of the carpometacarpal (CMC) joint
2. The Convex/Concave Rule was applied in each case
3. 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
4. The physiotherapist takes the right thumb metacarpal bone of the subject with his right thumb and index finger and makes a specific Kaltenborn’s mobilization of posterior-anterior gliding of a short amplitude with distraction of the CMC joint for 3 minutes with a 1 minute pause. The action is repeated three times.
5. The physiotherapist distracts the joint retracting from the thumb and glides the first metacarpal bone in a posterior-anterior orientation
6. 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
7. The gliding movement respects the rule of convexity-concavity of the joint

Placebo technique:
1. Participants in the placebo group attended the same number of sessions as did those in the Kaltenborn mobilization group, but they received intermittent ultrasound therapy for 10 minutes each that was non-therapeutic to the thumb region

Co-sponsor:
Rey Juan Carlos University (Universidad Rey Juan Carlos)
Deapartment of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Alcorcón, Spain

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, Connecticut, 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:
2.1. Pinch strength:
2.1.1. 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°
2.1.2. 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 2.1.3. The reliability of this procedure to measure the pinch strength has been found to be on the order of 0.93
2.2. Grip strength measurements:
2.2.1. 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
2.2.2. The reliability of the measurements was expressed by ICC between 0.82 and 0.97 for grip strength measurements

Secondary outcome measures

No secondary outcome measures

Overall trial start date

30/05/2011

Overall trial end date

30/06/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Patients who used the dominant hand systematically such as ex-factory workers and home workers, and were diagnosed with secondary carpometacarpal osteoarthritis in the dominant hand by X-ray detection of stage III and IV according to the Eaton-Littler-Burton Classification

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

29 patients

Participant exclusion criteria

1. With a medical history of carpal tunnel syndrome
2. Arthritis
3. Surgical interventions on CMC joint
4. Patients with D’Quervain’s tenosynovitis were also excluded
5. Patients presenting degenerative or non-degenerative neurological conditions in which pain perception was altered

Recruitment start date

30/05/2011

Recruitment end date

30/06/2011

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

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Other

Funder name

Investigator initiated and funded (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