Osteoarthritis of the Hip or Knee Clinical Trial
Official title:
A Comparison of Kneipp Hydrotherapy With Conventional Physiotherapy in the Treatment of Osteoarthritis of the Hip or Knee: Protocol of a Prospective Randomised Controlled Clinical Trial
The study design consists of a prospective randomised controlled three-armed clinical trial, which will be carried out at a specialist clinic for integrative medicine, to investigate the clinical effects of hydrotherapy on osteoarthritis of the knee or hip joint, in comparison with conventional physiotherapy.
The main aim of this three-armed clinical study will be to determine the effects of
hydrotherapy with alternate cold and warm affusions of the thigh in the concomitant
treatment of osteoarthritis of the hip or knee. The main outcome measures are pain
reduction, improvement in the quality of life, and increased movement in the affected joint.
Research questions
1. Does Kneipp hydrotherapy show a measurable effect in the sense of altered clinical
findings in the affected knee or hip joint?
2. How effectively does hydrotherapy influence the clinical parameters of pain, range of
movement, and function of the affected joint?
3. How effectively does hydrotherapy affect the secondary outcome measures of quality of
life, pain experienced, mood, and blood pressure?
4. Do hydrotherapeutic applications simply provide short-term therapeutic success or are
there long-term changes in the clinical findings?
5. Are the clinical effects of hydrotherapy comparable with those of conventional
physiotherapy of the affected joint?
6. Are the clinical effects of hydrotherapy used as monotherapy comparable with a
combination of hydrotherapy and physiotherapy of the affected joint?
7. Do unwanted effects or side effects occur with hydrotherapy?
This study was designed as a prospective randomised controlled clinical trial with three
arms, which is to be carried out at a German clinic specialised in integrative medicine, to
investigate the clinical effects of hydrotherapy on osteoarthritis of the knee or hip, as
compared with conventional physiotherapy.
To achieve maximum scientific accuracy with respect to randomisation, random distribution,
avoidance of selection bias, etc., the independent Department of General Medicine and
Primary Care of the University of Leipzig Medical School will function as an external
evaluation and testing centre.
The design and concept of this study, as well as its ethical validity, were reviewed and
approved by the Ethics Committee of the Bavarian State Chamber of Physicians
[Ethikkommission der Bayerischen Landesärztekammer], (Study Number 08032, dated 04.05.2008).
One hundred and eighty patients diagnosed with osteoarthritis of hip or knee will be
randomly assigned to one of three intervention groups: hydrotherapy, physiotherapy, and both
physiotherapy and hydrotherapy of the affected joint. In the first group, patients will
receive Kneipp hydrotherapy daily, with water applied in the form of alternate cold and warm
thigh affusions (alternating cold and warm water stimulation is particularly relevant to the
knee and hip regions).
Patients in the second group will receive physiotherapy of the hip or knee joint three times
a week. Patients in the physiotherapy-hydrotherapy combination group will receive both
joint-specific physiotherapy three times a week and alternate cold and warm thigh affusions
every day.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01066676 -
Dexibuprofen 400 mg Sachet Versus Ibuprofen 400 mg Sachet in Patients With Osteoarthritis of the Hip or Knee
|
Phase 4 |