Condition category
Musculoskeletal Diseases
Date applied
04/08/2012
Date assigned
09/08/2012
Last edited
09/08/2012
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

Reg. Generala 11/16
Piossasco
10045
Italy
mail@villafane.it

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Bilateral sensory and motor effects of unilateral combined treatment in patients with carpo-metacarpal osteoarthritis: a randomized clinical trial

Acronym

Study hypothesis

Thumb carpo-metacarpal (CMC) osteoarthritis (OA) is a common condition after the age of 50, especially in female. The main cause of thumb CMC OA is a degenerative progressive alteration of the thumb CMC joint. This degeneration includes chronic deterioration of superficial surfaces of the joint and ectopic bone regeneration, which results in pain at the base of the thumb.

Central sensitization is defined as an intensification of the responsiveness of central pain-signaling neurons from low-threshold mechanoreceptors. Central sensitization includes changes in sensory processing and down regulation of descending pain-inhibitory mechanisms. The importance of central sensitization processes underlies a mechanism of pain in OA pain which has recently gained interest.

Ethics approval

Local Health Authority, Collegno, Italy [Residenze Sanitarie Assistenziali Azienda Sanitaria Locale], 10 December 2008, 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 carpo-metacarpal osteoarthritis

Intervention

Treatment group

Kaltenborn mobilization:
1. The therapist grasps the right thumb metacarpal bone of the patient with his right thumb-index fingers and
2. The therapist distracts the joint retracting the thumb and gliding the first metacarpal bone in a posterior-anterior direction.
3. A posterior-anterior gliding of short amplitude with distraction of the thumb CMC joint was applied for 3 minutes with a 1 minute pause.
4. The mobilization sequence was repeated 3 times.

Median nerve mobilization.
1. The patient was positioned in supine and the therapist was seated.
2. The physical therapist induces shoulder girdle depression, gleno-humeral abduction and lateral rotation, supination of the forearm, wrist, thumb, and finger extension of the patient’s arm.
3. The slider neurodynamic technique of the median nerve consists of alternation of elbow extension (loads the median nerve) and wrist flexion (unloads the median nerve), with elbow flexion (unloading) and wrist extension (loading).
4. The range of motion was: wrist 0-60° extension; elbow 90-165° extension depending on the tissue resistance.
5. The slider intervention was completed over 5-10 minutes in two sets of 5min each with 1min rest between sets.
6. Speed and amplitude of movement were adjusted such that no pain was produced during the technique.

Radial nerve mobilization:
1. Treatment was performed in six sessions over four weeks and was applied to the dominant hand three times during a four-minute period with one-minute pauses between periods
2. The technique consisted of a sliding mobilization of the proximal-distal radial nerve
3. To begin the technique, the patient was positioned in supine and the physiotherapist was seated
4. The physiotherapist depressed the patient’s shoulder girdle, extended the patient’s elbow and then internally rotated the arm
5. The patient’s wrist, thumb and all the fingers were flexed. Finally ulnar deviation of the hand was added.
6. This combination of movements is hypothesized to cause stress the radial nerve
7. Once the upper extremity was positioned two movements were done as follows:
7.1. Soulder depression was applied simultaneously with elbow flexion and wrist extension
7.2. Shoulder elevation is performed with elbow extension and wrist flexion and ulnar deviation
8. These motions are alternated at a rate of approximately 2 seconds per cycle (1 second into extension and 1 second into flexion).

Hand Excercises:
The first six exercises consisted of active range of motion movements of the hand designed to improve joint flexibility. The last three exercises were designed to strengthen grip and pinch grips by using a non-latex polymer ball: the Thera-Band Hand Exerciser (The Hygenic Corporation, Akron, OH). The hand exerciser is color coded by approximate resistance level at 50% compression, with yellow at 0.68 kg, red at 1.36 kg, green at 2.27 kg, and blue at 3.64 kg.

Placebo technique (control):
1. Participants in the placebo group attended the same number of sessions as those in the treatment group, but they received intermittent ultrasound therapy for 10 minutes with an intensity of 0 watts/cm^2 to on the hypothenar area of the dominant hand
2. Gel was used as required

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Mechanical pain sensitivity:
1.1. Pain sensitivity was determined by measuring pressure pain threshold (PPT)
1.2. Measurements were performed with a Mechanical Pressure Algometer (Wagner Instruments, Greenwich, Connecticut, USA) with a 1cm2 rubber-tipped plunger mounted on a force transducer was used for measuring PPT
1.3. Pressure was applied at a rate of 30 kPa/s
1.4. The mean of three measurements was calculated and used for the main analysis
1.5. Previous papers have reported an intraexaminer reliability of this procedure ranging from 0.6 to 0.97, while the interexaminer reliability ranged from 0.4 to 0.98
1.6. The following points were evaluated:
1.6.1. TM joint at the bottom of the anatomical snuffbox, tubercle of the scaphoid bone and unciform apophysis of the hamate bone
1.6.2. Three measurements were made with a one-minute pause between them
1.6.3. Although pain from deep tissue is difficult to assess precisely, PPT have been found useful in assessing pain reactions in OA patients
2. Pain evaluation:
2.1. The main outcome of the study was pain intensity.
2.2. The intensity of thumb CMC joint pain was assessed with a 100mm visual analogue scale (VAS).
2.3. The VAS is a 100mm line anchored with a 0 at one end representing no pain and 100 at the other end representing the worst pain imaginable.
2.4. The VAS was selected as the main outcome measure based on its ability to detect changes with a minimal clinically important difference (MCID) ranging from 9 to 11 mms.
3. Motor performance:
3.1. Pinch strength
3.1.1. The pinch strength was evaluated with a mechanical pinch gauge (Baseline, NY, USA) in the sitting position with the shoulder adducted and neutrally rotated and the elbow flexed at 90°
3.1.2. Two different measurements were taken. First we measured the tip pinch between index and thumb fingers. Then we measured tripod pinch, between index and, middle fingers and the thumb.
3.1.3. The reliability of pinch strength has been found to be high (Intra-class correlation coefficient [ICC]= 0.93).
3.2. Grip strength
3.2.1. Grip strength was assessed with a grip dynamometer (Baseline, NY, USA) with the patient in the sitting position.
3.2.2. This procedure has shown to have a precision of ± 3% (15-17).
3.2.3. The reliability of grip strength has been reported to be high (ICC: 0.82- 0.97).

Measurements were taken before intervention, after 1 month, 1st Follow-up and 2 months, 2nd follow up.

Secondary outcome measures

1. The Beck Depression Inventory (BDI)
1.1. Review of internal consistency for the BDI ranges from 0.73 to 0.92, with a mean of 0.86, with alpha coefficients of 0.86 and 0.81 for psychiatric and non-psychiatric populations, respectively
1.2. The BDI observed showed high discrimination of depressive symptoms (75-100%)
2. State-Trait Anxiety Inventory (STAI)
2.1. This is a self rated questionnaire divided in two parts: anxiety-trait (referring to personality aspects) and anxiety-state (referring to systemic aspects of the context)
2.2. Responses are in a 1-4 scale
2.3. Anxiety-state refers to how individuals feel “at the moment” and anxiety-trait to how they “generally feel”
2.4. Each part varies from 20 to 80 points, and the scores indicate low (0-30), medium (31-49) or high (50 or more) anxiety levels

Measurements were taken before intervention, after 1 month (1st follow-up) and 2 months (2nd follow up)

Overall trial start date

16/01/2012

Overall trial end date

14/04/2012

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 (CMC OA) 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

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. Patients if they scored more than 4 on the Beck’s Depression Inventory and/or more than 30 on the State Trait Anxiety Inventory (STAI)
2. Patients with a medical history of carpal tunnel syndrome, arthritis, surgical interventions on the thumb CMC joint, or D’Quervain’s tenosynovitis.
3. Patients presenting degenerative or non-degenerative neurological conditions in which pain perception was altered

Recruitment start date

16/01/2012

Recruitment end date

14/04/2012

Locations

Countries of recruitment

Italy

Trial participating centre

Reg. Generala 11/16
Piossasco
10045
Italy

Sponsor information

Organisation

Local Health Authority, Collegno [Azienda Sanitaria Locale, Collegno] (Italy)

Sponsor details

c/o Dr Jorge Hugo Villafañe
Via C. colombo 2/9
Collegno
10093
Italy
mail@villafane.it

Sponsor type

Government

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