PST: Periosteal Stimulation for Knee Osteoarthritis

• Sponsor: US Department of Veterans Affairs (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00865046
• Collaborator: (none)
• Enrollment: 190
• Location: 1
• Arms: 3
• Duration (Months): 46
• Patients Per Site Per Month: 4.1

Study Details

Study Description

Brief Summary

185 veterans with chronic knee pain and advanced knee osteoarthritis will be recruited to participate in this study designed to test the effectiveness of a special type of electrical acupuncture called periosteal stimulation (PST). Participants will be divided into three groups. They will receive PST or a control condition once a week for 10 weeks. Two-thirds of the participants will receive booster sessions periodically over the course of the next 6 months. Everyone will be called monthly during the 6 month period and then will be asked to return for an evaluation on site at the end of this period.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Knee	Other: Periosteal stimulation; Other: Control-Periosteal Stimulation	N/A

Detailed Description

We have performed a promising initial trial of periosteal stimulation (PST, that is, electrical stimulation of 4 acupuncture needles around the knee that touch periosteum) as an analgesic for older veterans with advanced knee osteoarthritis (OA) and daily pain. The primary aim of the proposed trial is to optimize and sustain the efficacy of PST for reducing pain in veterans with advanced knee OA and unrelieved pain by combining it with booster PST. Our secondary aims are to 1) improve physical performance in these individuals, and 2) ascertain the physical and psychological predictors of response to PST. In a randomized controlled clinical trial, 180 veterans (age 50 and older) with persistent knee pain who have x-ray evidence of advanced OA will be assigned to one of three intervention groups: 1) control PST once a week for 10 weeks (i.e., needle placement with brief stimulation of non-periosteal needles), 2) PST once a week for 10 weeks followed by tapering PST boosters over 6 months, or 3) PST once a week for 10 weeks followed by tapering control-PST boosters over 6 months. Prior to initiating the intervention, immediately after the last session, and 6 months later, the following parameters will be assessed: 1) pain severity (WOMAC), 3) physical performance (gait velocity, stair climb, repetitive chair rise, timed up and go), and 4) psychological function (mood, coping, self-efficacy). Monthly telephone calls will assess pain, interim illness and physical activity.

Study Design

• Study Type: Interventional
• Actual Enrollment: 190 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single
• Primary Purpose: Treatment
• Official Title: Efficacy of Periosteal Stimulation and Boosters for Advanced Knee OA Pain
• Study Start Date: Nov 1, 2009
• Actual Primary Completion Date: Sep 1, 2013
• Actual Study Completion Date: Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PST + PST boosters PST once a week for 10 weeks, then tapering over 6 months	Other: 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.
Active Comparator: PST + control-PST boosters PST once a week for 10 weeks, then control-PST tapering over 6 months	Other: 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.; Other: Control-Periosteal Stimulation; Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute.
Placebo Comparator: Control-PST control-PST for 10 weeks	Other: Control-Periosteal Stimulation; Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute.

Outcome Measures

Primary Outcome Measures

1. Pain (WOMAC) [9 months following baseline]

   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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 89 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• English speaking,

• Knee pain on most days of the past 3 months that is more severe than pain in other parts of the lower body,

• Advanced knee OA by x-ray,

• age 50-89

Exclusion Criteria:

• Non-ambulatory or severely impaired mobility (i.e., require the use of a walker),

• Folstein MMSE < 24,

• Severe uncorrected visual or hearing impairment,

• Knee pain due to factors other than OA,

• Large knee effusion,

• History of corticosteroid or hyaluronic acid injection in the affected knee(s) during the preceding 3 months,

• Acute or terminal illness,

• Immune suppression,

• Anticoagulation therapy,

• Pacemaker,

• Prior PST treatment

• Active participation in other studies currently

• Age >89

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Geriatric Research, Education, and Clinical Center	Pittsburgh	Pennsylvania	United States	15206

Sponsors and Collaborators

• US Department of Veterans Affairs

Investigators

• Principal Investigator: Debra K. Weiner, MD, Geriatric Research, Education, and Clinical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: US Department of Veterans Affairs
• ClinicalTrials.gov Identifier: NCT00865046
• Other Study ID Numbers: A6614-R
• First Posted: Mar 19, 2009
• Last Update Posted: Jan 26, 2015
• Last Verified: Jan 1, 2015

• Keywords provided by US Department of Veterans Affairs: acupuncture
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee

Study Results

Participant Flow

Arm/Group Title	Arm 1	Arm 2	Arm 3
Arm/Group Description	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.	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.	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.
Period Title: Overall Study
STARTED	63	64	63
COMPLETED	57	59	62
NOT COMPLETED	6	5	1

Baseline Characteristics

Arm/Group Title	Arm 1	Arm 2	Arm 3	Total
Arm/Group Description	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.	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.	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 of all reporting groups
Overall Participants	63	64	63	190
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67.1 (8.9)	65.8 (8.7)	66.8 (10.4)	66.5 (9.3)
Sex: Female, Male (Count of Participants)
Female	8 12.7%	10 15.6%	11 17.5%	29 15.3%
Male	55 87.3%	54 84.4%	52 82.5%	161 84.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 3.2%	0 0%	0 0%	2 1.1%
Not Hispanic or Latino	61 96.8%	64 100%	63 100%	188 98.9%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	18 28.6%	22 34.4%	16 25.4%	56 29.5%
White	45 71.4%	42 65.6%	47 74.6%	134 70.5%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	63 100%	64 100%	63 100%	190 100%
WOMAC (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	9.0 (3.2)	9.9 (4.0)	10.6 (3.6)	9.8 (3.6)
Short Physical Performance Battery (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	6.1 (1.8)	6.1 (1.9)	6.2 (1.5)	6.1 (1.7)
Timed stair climb (seconds) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [seconds]	12.5 (4.7)	14.5 (7.8)	13.9 (7.3)	13.6 (6.6)
Timed Up and Go (seconds) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [seconds]	12.3 (3.4)	13.1 (3.8)	13.9 (6.9)	13.1 (4.7)
CES-D (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	11.7 (10.3)	14.7 (11.2)	12.3 (9.6)	12.9 (10.4)
Cognitive Strategies Questionnaire, catastrophizing scale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	7.9 (7.8)	12.1 (9.7)	8.8 (9.2)	9.6 (8.9)
BMI (kg/m2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m2]	31.6 (6.5)	33.1 (6.2)	32.5 (6.9)	32.4 (6.5)
Mean number of pain medications (medication) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [medication]	1.1 (1.0)	1.2 (0.9)	1.0 (0.9)	1.1 (0.9)
Mean number of opioids (opioids) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [opioids]	0.1 (0.3)	0.3 (0.6)	0.2 (0.4)	0.2 (0.4)
Duration of knee pain (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	5.7 (6.4)	6.2 (6.8)	7.2 (8.3)	6.4 (7.2)
Arthritis Self-Efficacy score, pain (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	64.3 (21.6)	59.5 (22.6)	63.9 (21.7)	62.6 (22)
Arthritis Self-Efficacy score, function (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	77.5 (17.0)	76.3 (16.9)	76.1 (16.4)	76.6 (16.8)
Arthritis Self-Efficacy score, other symptoms (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	70.5 (21.1)	65.9 (20.3)	68.6 (20.9)	68.3 (20.8)

Outcome Measures

1. Primary Outcome

Title	Pain (WOMAC)
Description	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)
Time Frame	9 months following baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1	Arm 2	Arm 3
Arm/Group Description	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.	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.	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.
Measure Participants	57	59	62
Mean (Standard Error) [units on a scale]	6.1 (3.5)	6.6 (3.6)	7.9 (7.7)

Adverse Events

Arm/Group Title	Arm 1		Arm 2		Arm 3
Arm/Group Description	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.		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.		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.
All Cause Mortality
	Arm 1		Arm 2		Arm 3
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Arm 1		Arm 2		Arm 3
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/63 (4.8%)		1/64 (1.6%)		1/63 (1.6%)
Cardiac disorders
Myocardial Infarction	1/63 (1.6%)	1	0/64 (0%)	0	0/63 (0%)	0
Gastrointestinal disorders
Bowel obstruction	1/63 (1.6%)	1	0/64 (0%)	0	0/63 (0%)	0
General disorders
Death	1/63 (1.6%)	1	0/64 (0%)	0	0/63 (0%)	0
Infections and infestations
abscess	0/63 (0%)	0	1/64 (1.6%)	1	0/63 (0%)	0
Respiratory, thoracic and mediastinal disorders
Dyspnea	0/63 (0%)	0	0/64 (0%)	0	1/63 (1.6%)	1
Other (Not Including Serious) Adverse Events
	Arm 1		Arm 2		Arm 3
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/63 (4.8%)		0/64 (0%)		1/63 (1.6%)
General disorders
sweating	0/63 (0%)	0	0/64 (0%)	0	0/63 (0%)	0
Lightheaded	1/63 (1.6%)	1	0/64 (0%)	0	0/63 (0%)	0
Musculoskeletal and connective tissue disorders
Pain	1/63 (1.6%)	1	0/64 (0%)	0	1/63 (1.6%)	1
Skin and subcutaneous tissue disorders
Bruising	1/63 (1.6%)	1	0/64 (0%)	0	0/63 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.