The aim of this pilot study is to analyse the effects of two different hand therapy treatments after flexor tendon repair. These two hand therapy treatments concern the active mobilization protocol of the Belfast regime and the passive mobilization…
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
- Soft tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Joint mobility: Total Active Motion (TAM) and Total Passive Motion (TPM)
measured with digital goniometry
- Strength measured with the digital dynamometer
- Michigan Hand Outcomes Questionnaire (MHQ). A questionnaire of the hand
function in general, activities of daily living, quality of life, working
performance, pain, aesthetics and the satisfaction with the hand.
- The (Quick) DASH (Disabilities of the Arm, Shoulder and Hand); a
questionnaire the ability to perform daily activities with the upper limb,
based on the condition at that moment.
- The Perdue Pegboard test; ability test of the fine motor control.
- Number of tendon ruptures and other complications like infection, bleeding,
wound dehiscence.
- Moment of the return to work (in days).
- Duration of the therapy and the number of therapy sessions. This will be
recorded by the hand therapist.
- The total costs of treatment. This calculation is based on working hours and
material costs.
Secondary outcome
Not applicable.
Background summary
The post-operative treatment of flexor-tendon injuries is based on the
knowledge of the nutrition and healing of the tendons. Until the late 70ties
people where convinced that the main part of the healing was extrinsic,
therefore they prescribed total immobilization.
Later on more knowledge became available on the intrinsic healing of the tendon.
At that moment Kleinert and Duran & Houser developed the passive mobilisation
protocols, which provides a better sliding capability of the tendon. They used
a dynamic splint with the fingers hold in a flexion position by elastic cords
and made active extension only possible when allowed. The results of this
treatment where better than the results of the total immobilization.
Over the last years the treatment according to Kleinert is improved in many
different ways (the modified Kleinert protocols) with alterations in the
position of the joints in the splint. Furthermore, several protocols concerning
early active mobilization were developed (Chow, Belfast, Elliot). These
protocols differ on details. Beside the active extension in a post-operative
early stage, active flexion is allowed as well. The profit of the active
treatment is that by active contraction of the muscle, a better sliding
capability of the tendon is achieved. In active treatment the tendon is drawn
through the tendon sheath instead of pushing the oedematous tendon through the
sheath as is the case in the passive treatment protocol. The disadvantage of
the active mobilization procedure is the higher risk of a rupture of the
sutured tendon
Different study analyses of the effectiveness of the methods described above
were made, but the literature can*t give a clear preference between the active
or passive treatment after flexor tendon repair. Accurate randomised controlled
trials are, up till now, not accomplished.
Study objective
The aim of this pilot study is to analyse the effects of two different hand
therapy treatments after flexor tendon repair. These two hand therapy
treatments concern the active mobilization protocol of the Belfast regime and
the passive mobilization treatment by the modified Kleinert protocol.
Study design
Randomized controlled trial
Study burden and risks
Not applicable
Hanzeplein 1
9700 RB Groningen
NL
Hanzeplein 1
9700 RB Groningen
NL
Listed location countries
Age
Inclusion criteria
the patient is 18 years of age or older
the patient has an isolated Zone II flexor tendon injury of the FDP and/or FDS (Flexor Digitorum Profundus and/or Superficialis)
The patient is able to execute instructions of the hand therapist or the researcher.
The patient has a sufficient command of the Dutch language
Exclusion criteria
-comorbidity interfering with hand function
-phalangeal fractures
-psychological-, alcohol-, and/or drug induced problems
-extensive soft tissue (skin) lesions
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL19142.042.08 |