Periosteal Stimulation for Knee Osteoarthritis (PST)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00865046
First received: March 17, 2009
Last updated: January 22, 2015
Last verified: January 2015
Results First Received: December 10, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind;   Primary Purpose: Treatment
Condition: Osteoarthritis, Knee
Interventions: Other: Periosteal stimulation
Other: Control-Periosteal Stimulation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Arm 1

PST once a week for 10 weeks, then tapering over 6 months

Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute.

Arm 2

PST once a week for 10 weeks, then control-PST tapering over 6 months

Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute.

Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute.

Arm 3

control-PST for 10 weeks

Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute.


Participant Flow:   Overall Study
    Arm 1     Arm 2     Arm 3  
STARTED     63     64     63  
COMPLETED     57     59     62  
NOT COMPLETED     6     5     1  
Lost to Follow-up                 1                 4                 0  
Death                 0                 1                 1  
Withdrawal by Subject                 5                 0                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Community dwelling adults with advanced knee osteoarthritis and chronic pain

Reporting Groups
  Description
Arm 1

PST once a week for 10 weeks, then tapering over 6 months

Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute.

Arm 2

PST once a week for 10 weeks, then control-PST tapering over 6 months

Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute.

Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute.

Arm 3

control-PST for 10 weeks

Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute.

Total Total of all reporting groups

Baseline Measures
    Arm 1     Arm 2     Arm 3     Total  
Number of Participants  
[units: participants]
  63     64     63     190  
Age  
[units: years]
Mean ± Standard Deviation
  67.1  ± 8.9     65.8  ± 8.7     66.8  ± 10.4     66.5  ± 9.3  
Gender  
[units: participants]
       
Female     8     10     11     29  
Male     55     54     52     161  
Ethnicity (NIH/OMB)  
[units: participants]
       
Hispanic or Latino     2     0     0     2  
Not Hispanic or Latino     61     64     63     188  
Unknown or Not Reported     0     0     0     0  
Race (NIH/OMB)  
[units: participants]
       
American Indian or Alaska Native     0     0     0     0  
Asian     0     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0     0  
Black or African American     18     22     16     56  
White     45     42     47     134  
More than one race     0     0     0     0  
Unknown or Not Reported     0     0     0     0  
Region of Enrollment  
[units: participants]
       
United States     63     64     63     190  
WOMAC [1]
[units: units on a scale]
Mean ± Standard Deviation
  9.0  ± 3.2     9.9  ± 4.0     10.6  ± 3.6     9.8  ± 3.6  
Short Physical Performance Battery [2]
[units: units on a scale]
Mean ± Standard Deviation
  6.1  ± 1.8     6.1  ± 1.9     6.2  ± 1.5     6.1  ± 1.7  
Timed stair climb [3]
[units: seconds]
Mean ± Standard Deviation
  12.5  ± 4.7     14.5  ± 7.8     13.9  ± 7.3     13.6  ± 6.6  
Timed Up and Go [4]
[units: seconds]
Mean ± Standard Deviation
  12.3  ± 3.4     13.1  ± 3.8     13.9  ± 6.9     13.1  ± 4.7  
CES-D [5]
[units: units on a scale]
Mean ± Standard Deviation
  11.7  ± 10.3     14.7  ± 11.2     12.3  ± 9.6     12.9  ± 10.4  
Cognitive Strategies Questionnaire, catastrophizing scale [6]
[units: units on a scale]
Mean ± Standard Deviation
  7.9  ± 7.8     12.1  ± 9.7     8.8  ± 9.2     9.6  ± 8.9  
BMI  
[units: kg/m2]
Mean ± Standard Deviation
  31.6  ± 6.5     33.1  ± 6.2     32.5  ± 6.9     32.4  ± 6.5  
Mean number of pain medications [7]
[units: medication]
Mean ± Standard Deviation
  1.1  ± 1.0     1.2  ± 0.9     1.0  ± 0.9     1.1  ± 0.9  
Mean number of opioids [8]
[units: opioids]
Mean ± Standard Deviation
  0.1  ± 0.3     0.3  ± 0.6     0.2  ± 0.4     0.2  ± 0.4  
Duration of knee pain  
[units: years]
Mean ± Standard Deviation
  5.7  ± 6.4     6.2  ± 6.8     7.2  ± 8.3     6.4  ± 7.2  
Arthritis Self-Efficacy score, pain [9]
[units: units on a scale]
Mean ± Standard Deviation
  64.3  ± 21.6     59.5  ± 22.6     63.9  ± 21.7     62.6  ± 22  
Arthritis Self-Efficacy score, function [10]
[units: units on a scale]
Mean ± Standard Deviation
  77.5  ± 17.0     76.3  ± 16.9     76.1  ± 16.4     76.6  ± 16.8  
Arthritis Self-Efficacy score, other symptoms [11]
[units: units on a scale]
Mean ± Standard Deviation
  70.5  ± 21.1     65.9  ± 20.3     68.6  ± 20.9     68.3  ± 20.8  
[1]

The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) consists of 24 items divided into 3 subscales:

Pain (5 items), score range 0-20 Stiffness (2 items): score range 0-8 Physical Function (17 items): score range 0-68 Total score ranges from 0 (best possible outcome) to 96 (worst possible outcome)

[2]

The SPPB measures performance on 3 items:

  1. Repeated chair stands (number of stands and time to complete as well as a 0-4 ordinal scale))
  2. Balance testing - semitandem stand, side-by-side stand, and tandem stand; each scored as 2 (held for 10 sec), 1 (held for less than 10 sec), 0 (not attempted) as well as a 0-4 ordinal scale for overall balance performance
  3. 8 foot walk - 0-4 scale according to velocity Summary ordinal score: 0 (worst performance) to 12 (best performance)
[3] Participants were timed as they ascended and descended 5 steps.
[4] The Timed Up and Go (TUG) measures mobility and falls risk. The participant sits in a chair and is timed as (s)he stands up from the chair, walks 3 meters, turns around, walks back to the chair and sits down. The result is expressed in seconds. An older adult who takes at least 12 seconds to complete the TUG is at high risk for falling.
[5] The Center for Epidemiological Studies-Depression (CES-D) scale is a measure of depressive symptoms. It is a 20 item. Each item is scored from 0 (rarely or none of the time) to 3 (most or all of the time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms.
[6] The catastrophizing scale of the Cognitive Strategies Questionnaire consists of 6 items, each scored from 0 (never state that) to 6 (always state that). The scoring range on the instrument is 0 (best pain coping) to 36 (worst pain coping).
[7] Mean number of pain medications per day
[8] Mean number of opioids per day
[9] This is the pain subscale of The Arthritis Self-Efficacy Scale (ASES). The ASES consists of 20 questions divided into three subscales: physical function (9 questions), other symptoms (6 questions) and pain (5 questions). Participants are asked about their level of certainty that they can perform each task. Each question is scored from 10 = very uncertain to 100 = very certain. Each subscale is scored separately by taking the mean score of the items. Higher scores indicate higher self-efficacy. The range for the pain subscale is 10 to 100.
[10] This is the physical function subscale of The Arthritis Self-Efficacy Scale (ASES). The ASES consists of 20 questions divided into three subscales: physical function (9 questions), other symptoms (6 questions) and pain (5 questions). Participants are asked about their level of certainty that they can perform each task. Each question is scored from 10 = very uncertain to 100 = very certain. Each subscale is scored separately by taking the mean score of the items. Higher scores indicate higher self-efficacy. The range for the physical function subscale is 10 to 100.
[11] This is the other symptoms subscale of The Arthritis Self-Efficacy Scale (ASES). The ASES consists of 20 questions divided into three subscales: physical function (9 questions), other symptoms (6 questions) and pain (5 questions). Participants are asked about their level of certainty that they can perform each task. Each question is scored from 10 = very uncertain to 100 = very certain. Each subscale is scored separately by taking the mean score of the items. Higher scores indicate higher self-efficacy. The range for the other symptoms subscale is 10 to 100.



  Outcome Measures

1.  Primary:   Pain (WOMAC)   [ Time Frame: 9 months following baseline ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Debra K. Weiner
Organization: VA Pittsburgh Healthcare System
phone: 412-360-2920
e-mail: debra.weiner@va.gov


Publications of Results:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00865046     History of Changes
Other Study ID Numbers: A6614-R
Study First Received: March 17, 2009
Results First Received: December 10, 2014
Last Updated: January 22, 2015
Health Authority: United States: Federal Government