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Trial registered on ANZCTR


Registration number
ACTRN12608000264381
Ethics application status
Approved
Date submitted
17/05/2008
Date registered
26/05/2008
Date last updated
26/05/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of physical therapy treatment on pain and physical functions in patients with osteoarthritis of the knee: comparative study of manual therapy, supervised exercises and electro acupuncture versus well-designed home exercise program
Scientific title
Effectiveness of physical therapy treatment on pain and physical functions in patients with osteoarthritis of the knee: comparative study of manual therapy, supervised exercises and electro acupuncture versus well-designed home exercise program
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
osteoarthritis 3167 0
Condition category
Condition code
Musculoskeletal 3323 3323 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
physical therapy program composed of manual therapy, supervised exercises and electro acupuncture
Manual therapy (Mobilizing exercises) was performed for 20 minutes 3 times /week for 8 weeks.
(Supervised exercises) Flexibility exercises were done to gastrocnemius-soleus, hamstring and quadriceps muscle by ask patient to hold the muscle stretch for 30 seconds and do three repetitions with each muscle group on each leg. The strengthening exercises consisted of quadriceps and hamstring "sitting" followed by maximal isometric contractions of the quadriceps and hamstrings. The active range of motion maneuvers performed were straight leg raises (hip), abduction/adduction (hip), short arc extension (knee), leg extensions (knee) and leg curls (knee)., strength, endurance and active range of motion activities . the session extended to about 20 minutes and repated 3 times/week for 8 weeks (total time of exercises about 40 minutes as long as there is no pain or muscle fatigue
The EA treatment lasted for 20 minutes 3 times/week for 8 weeks at the 9 selected acupuncture points.
Intervention code [1] 2896 0
Treatment: Other
Comparator / control treatment
well-designed home exercise program
the exercises performed daily for 45 minutes divided into 3 times per day for 8 weeks The physical therapist reassessed the exercise program after 4weeks for each patient to keep the program challenging and beneficial. The patients were made aware of the side effects and contraindications (swelling, increase joint pain) of excessive exercise
Control group
Dose comparison

Outcomes
Primary outcome [1] 4211 0
The mean change of pain scores was assessed on 100 mm visual analogue scale (VAS).
Timepoint [1] 4211 0
pain was measured at the beginning and at the end of 8 weeks of treatment.
Secondary outcome [1] 7126 0
Physical function
Western Ontario Mc Master's Arthritis Index (WOMAC) questionnaire (Arabic translation, appendix I) The WOMAC is divided into three dimensions: pain, stiffness and physical function listed in 24 items. The Likert scale (a verbal scale of five points: none = 0, slight =1, moderate = 2, severe = 3, extreme = 4) is used for scoring each item
Timepoint [1] 7126 0
physical functions were measured at the beginning and at the end of 8 weeks of treatment

Eligibility
Key inclusion criteria
The main inclusion criterion was a diagnosis of osteoarthritis of the knee based on fulfillments of one of the following clinical criteria developed by Altman and colleagues1986,(18): 1) knee pain, age 38 years or younger, and bony enlargement; 2) knee pain, age 39 years or older, morning stiffness for more than 30 minutes, and bony enlargement; 3) knee pain, crepitus on active motion, morning stiffness for more than 30 minutes, and bony enlargement; or 4) knee pain, crepitus on active motion, morning stiffness for more than 30 minutes, and the age 38 years or older. Altman and colleagues found these criteria to be 89% sensitive and 88% specific.
Minimum age
45 Years
Maximum age
55 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients were excluded if they could not attend the required number of visits, had received a cortisone injection to the knee joint within the previous 30 days or had a surgical procedure on either lower extremity in the past 6 months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
the subjects were allocated by sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The patients were randomly assigned equally to two groups. Clinic treatment group (Group A) designed to receive clinical based physical therapy program consists of manual therapy, supervised exercises and EA like TENS.
we select the pateints randomly by using randomisation table
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3415 0
Self funded/Unfunded
Name [1] 3415 0
Dr.Afaf Shaheen
Address [1] 3415 0
collage of physical therapy, Cairo university,doki, Giza
Country [1] 3415 0
Egypt
Primary sponsor type
Individual
Name
Dr.Afaf Shaheen
Address
collage of physical therapy, Cairo university,doki, Giza
Country
Egypt
Secondary sponsor category [1] 3059 0
None
Name [1] 3059 0
Address [1] 3059 0
Country [1] 3059 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The purpose of this study was to investigate the effectiveness of clinically applied treatment include manual therapy, supervising exercises and electro-acupuncture like TENS compared with well-designed home exercise program for OA of the knee.

Our hypothesis was that physical therapy consisting of manual therapy, supervised exercises and electro-acupuncture like TENS (EA like TENS) conducted in the clinic would be more effective than exercise program performed at home for decreasing pain and improving function.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28597 0
Address 28597 0
Country 28597 0
Phone 28597 0
Fax 28597 0
Email 28597 0
Contact person for public queries
Name 11754 0
Dr.Afaf Shaheen
Address 11754 0
collage of physical therapy, Cairo university,doki, Giza
Country 11754 0
Egypt
Phone 11754 0
37617693
Fax 11754 0
37617692
Email 11754 0
afafpt@yahoo.com
Contact person for scientific queries
Name 2682 0
Dr.Amaal Ebrahim
Address 2682 0
collage of physical therapy, Cairo university,doki, Giza
Country 2682 0
Egypt
Phone 2682 0
37617693
Fax 2682 0
37617692
Email 2682 0
amaal82_83@hotmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary