Radial nerve mobilization decreases pain sensitivity and improves motor performance in patients with thumb carpometacarpal osteoarthritis
| ISRCTN | ISRCTN81771317 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81771317 |
| Protocol serial number | N/A |
| Sponsors | Azienda Sanitaria Locale 3 (Italy), Rey Juan Carlos University (Universidad Rey Juan Carlos), Azienda Sanitaria Locale |
| Funder | Investigator initiated and funded (Italy) |
- Submission date
- 15/05/2011
- Registration date
- 26/05/2011
- Last edited
- 30/06/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Osteoarthritis is a condition that causes joints to become painful and stiff, such as the carpometacarpal (CMC) joint of the thumb. Thumb CMC osteoarthritis is a major cause of disability in Europe and the United States. In fact, 30-40% of postmenopausal women and 40-50 year-old men suffer from this condition. The main cause of thumb CMC osteoarthritis is deterioration of the surfaces of the joint and abnormal bone growth. This condition can be treated using surgery, but the results are usually only partially successful. Neurodynamic techniques are a form of manual therapy directed to the neural (nerve) structures through positioning and movement of multiple joints. Although there is only limited evidence to support its use in treatment, researchers have found small advantages in patients treated by this method; for example, certain neuropathic conditions and musculoskeletal pain disorders. There are two general methods used to apply neurodynamic techniques: sliding and tensioning. Sliding techniques, the focus of this current study, consist of alternating combinations of movement of least two joints in which one movement loads the nerve thus increasing tension in the nerve while the other movement simultaneously unloads the nerve which decreases the tension of the nerve. The aim of this study is to assess the effects of a manual therapy technique on pain and function in patients with thumb CMC osteoarthritis.
Who can participate?
Patients aged 70 to 90 with thumb CMC osteoarthritis
What does the study involve?
Participants are randomly allocated to either the treatment or the placebo (sham treatment) group. Treatment consists of mobilization of the radial nerve with an experimental sliding technique. Pain and pinch strength are measured before treatment and after one and two weeks. Participants in the placebo group attend the same number of sessions as those in the treatment group, but they receive ultrasound treatment for 10 minutes on the dominant hand (sham treatment).
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Azienda Sanitaria Locale 3 (Italy)
When is the study starting and how long is it expected to run for?
September 2010 to May 2011
Who is funding the study?
Investigator initiated and funded (Italy)
Who is the main contact?
Dr Jorge Villafañe
Contact information
Scientific
via c. Colombo 2/9
Piossasco
10045
Italy
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Radial nerve mobilization decreases pain sensitivity and improves motor performance in patients with thumb carpometacarpal osteoarthritis: a randomized controlled trial |
| Study objectives | Thumb carpometacarpal osteoarthritis (TCOA) constitutes a major cause of upper limb related-disability in Europe and the United States. In fact, 30-40% of postmenopausal women and 40-50 year-old men suffer from this condition. TCOA contributes to the largest number of osteoarthritis-related surgical procedures conducted in United States. The main cause of TCOA is the degenerative alteration of the trapeziometacarpal (TM) joint. This includes chronic deterioration of superficial surfaces of the joint and ectopic bone regeneration. These characteristics of TCOA result in increased pain at the base of the thumb. The primary intent in this study is to confirm that neurophysiological changes occur in response to this intervention and extend these findings to a different peripheral musculoskeletal pain condition. |
| Ethics approval(s) | Local Health Authority, Collegno, Italy (Residenze Sanitarie Assistenziali Azienda Sanitaria Locale 3 (A.S.L 3), Collegno Italy), ref: 93571/c |
| Health condition(s) or problem(s) studied | Thumb carpometacarpal osteoarthritis |
| Intervention | Radial nerve mobilization (treatment group): 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 patients' shoulder girdle, extended the patients elbow and then internally rotated the arm 5. The patients' 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) 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/cm2 to on the hypothenar area of the dominant hand 2. Gel was used as required |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Mechanical pain sensitivity: |
| Key secondary outcome measure(s) |
1. The Beck Depression Inventory (BDI) |
| Completion date | 30/05/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 60 |
| Key inclusion criteria | Patients who used the dominant hand systematically such as ex-factory workers and home workers, and were 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. |
| Key exclusion criteria | 1. Patients if they scored more than 4 on the Becks 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 trapeziometacarpal (TM) joint, or DQuervains tenosynovitis 3. Patients presenting degenerative or non-degenerative neurological conditions in which pain perception was altered |
| Date of first enrolment | 20/09/2010 |
| Date of final enrolment | 30/05/2011 |
Locations
Countries of recruitment
- Italy
Study participating centre
10045
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2012 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
30/06/2017: Plain English summary added.
