Frequently Asked Questions

What is the scientific basis for Prolotherapy?

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Prolotherapy is an established technique for healing lax, stretched, or torn joint ligaments and muscle tendons.  The technique consists of injecting a proliferant solution at the site of attachment of the ligament or tendon to the joint bone.  The proliferant solution consists of a combination of Procaine™ (local anesthetic) and glucose.  Platelet-rich plasma (PRP) is a variation of the standard proliferant solution.  The proliferant solution stimulates the formation of an inflammatory reaction at the site of the ligament or tendon sprain injury.  That inflammation attracts the presence of growth factors, which stimulate the proliferation of the cells of the ligament or tendon.  PRP consists of a platelets, which contain those same growth factors.  The stimulated ligament or tendon cells generate and lay down new ligament or tendon collagen tissue.  The proliferation of new collagen heals the ligament or tendon sprain injury.

Is Prolotherapy an “off-label” use of Procaine™ and Glucose?

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Dr. Clark uses the components of the proliferative solution in an “off-label” fashion, extended beyond the usual and customary recommendations of the Federal Drug Administration (FDA).  The efficacy of Prolotherapy is considered by the FDA, Medicare, and various insurance companies to have NOT been adequately demonstrated in the medical literature and, therefore is considered by those organizations as “investigative” in nature.  On the other hand, several reports in the medical literature have shown scientifically-proven efficacy of Prolotherapy–resulting in insurance coverage in certain locales.  Prolotherapy is taught and used at all major Osteopathic Medical Schools and is being used and taught at the University of Wisconsin Medical School, an allopathic, MD training program.

To what diagnoses is Prolotherapy applicable?

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Prolotherapy is an appropriate therapy for treating any ligament or tendon sprain injury resulting in joint laxity, instability, dysfunction, or pain.

What is the usual Prolotherapy procedure?

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The usual Prolotherapy technique requires delivering a small volume of proliferant solution to the injured ligament or tendon using the following procedure:

  1. The patient may receive a preparatory skin test for allergy to Procaine™ and other constituents of the proliferant solution.
  2. The patient may receive a pre-therapeutic dose of a non-anti-inflammatory analgesic.
  3. The patient may need manual realignment.
  4. The physician positions the patient, examines, and demarcates the injured ligament—minimal clothing will be moved aside or removed.
  5. The physician anesthetizes the injection sites.
  6. The physician will inject the proliferant solution into the injured ligaments or tendons at their bony attachment sites.

Is Prolotherapy painful?

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Injection of the proliferant solution may cause some short-lived pain since the ligaments or tendons are injured and are already tender to needle point.  This discomfort is only momentary.  Post-therapeutically, the inflammatory reaction may produce a dull, achy discomfort, which  lasts only one to three days.  Generally, the discomfort of Prolotherapy is over rated, especially when measured against its long-standing, beneficial  therapeutic effects.

What are the frequency and total number of treatment sessions required?

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This is always a “crystal ball” prognostication.  The extent of treatment required depends on the nature and severity of the patient’s sprain injury and the patient’s musculoskeletal constitution.  Based on sound clinical research, the usual frequency of repeated treatment sessions in this clinic is every three to four weeks.  For an average severity of injury, the total number of treatment sessions averages three sessions in this clinic.

What are the risks of doing no Prolotherapy?

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The possible risks of doing NO Prolotherapy are:

  • No relief of the pain.
  • Progressively worsened pain.
  • Continued or progressively worsened joint dysfunction, such as decreased range of motion.
  • Continued or progressively worsened degeneration of the joints involved with the ligament laxity.

In other words, a chronic ligament or tendon injury is unlikely to get better and it is more likely to get worse.

What are alternatives to Prolotherapy?

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Possible alternatives to Prolotherapy are:

  • Doing nothing.
  • Osteopathic or chiropractic manipulation.
  • Physical therapy
  • Sacral belt and other temporary splints and braces
  • Steroid injections, which may reduce the pain but not give lasting results—may even be injurious.
  • Surgical intervention.

What are the risks or complications of Prolotherapy?

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The potential risks or complications of Prolotherapy are the same as for any medical injection therapy (e.g., flu shot, penicillin shot, cortisone shot):

  • No effect from the treatment
  • Immediate pain at the injection site, lasting 100 hours (3-4 days) or more
  • Bruising of the general treatment area
  • Bleeding at the injection site
  • Fainting or dizziness
  • Post-therapeutic tendinosis pain flare
  • Post-therapeutic muscle spasm
  • Similar to risk of surgical intervention, temporary (transient) or permanent injury to cutaneous nerves or muscles at the injection site
  • Autonomic nervous system-related skin and sensory changes
  • Sensory numbness or pain, aching, or burning sensations, or
  • Motor paralysis
  • Spinal cord injury during back injections
  • Pneumothorax (air on the outside of the lung) during chest injections
  • Allergic reaction to one of the components of the proliferant solution.  This may be in the form of mild skin reactions or severe anaphylactic shock.  Consequently, a careful allergic history needs to be taken and if there is any question, skin testing is advisable and available.
  • Death from allergic complications of the treatment.

Is anticoagulation therapy a contraindication to receiving Prolotherapy?
Any patient who is taking any anticoagulation therapy, e.g., heparin, Coumadin (Warfarin), Plavix (Clopidogrel), is not a Prolotherapy candidate.  Note: 80 mg of Aspirin a day is acceptable.

Is smoking a contraindication to receiving Prolotherapy?

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Smoking cigarettes or any other tobacco nicotine source (e.g., pipe, cigar, snuff) significantly impedes the therapeutic (healing) effectiveness of Prolotherapy.  Subsequently, if the patient uses nicotine and chooses to pursue a series of Prolotherapy sessions, it is understood that the patient runs the risk of experiencing either delayed healing (requiring more than the statistical average number of sessions), incomplete healing, or no healing at all.

Are there any nutritional supplements that may help Prolotherapy in its healing effect?

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During the course of Prolotherapy treatment sessions, it would be helpful to take supplemental Vitamin C to take advantage of its facilitating the laying down of new collagen and healing the sprain injury “wound”.  A dosage of two to three grams of Vitamin C orally per day is recommended.  Some diarrhea may occur on initiating the Vitamin C supplementation, which is usually easily controlled by reducing the dosage.

Should the Prolotherapy patient take anti-inflammatory medications for pain relief of established joint pain and post-therapeutic pain?

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For the relief of established joint pain or post-therapeutic pain, DO NOT use any steroidal or nonsteroidal anti-inflammatory drugs (see list below)—neither prescribed, over-the-counter, oral, or injection—for two weeks prior to prolotherapy treatment and for four weeks following prolotherapy treatment.
Anti-inflammatory drugs include:

  • Steroidal drugs such as cortisone and prednisone and
  • Nonsteroidal drugs such as Advil, Alka Seltzer, Anaprox, Artrotec, Aspirin (acetylsalicylic acid), Bristel, Cataflam, Celebrex, Clinoril, Ecotrin, Excedrin, Feldene, Indocine, Lodine, Motrin (Ibuprofen), Naprosyn, Percodan, Vioxx, any Cox-2 inhibitors, or white willow bark derivatives.
  • Note: 80 mg of Aspirin a day for cardiovascular protection is acceptable.

For pain relief following Prolotherapy, the only acceptable analgesic drugs are those that are NOT anti-inflammatory.  These include:

  • Over-the-counter drugs such as Tylenol (acetaminophen) or
  • Prescribed Class II medications, such as codeine (e.g., Tylenol 3) or hydrocordone (e.g., Lorcet or Vicodin) or oxycodone (e.g., Percocet).

You are to follow the dosage directions as prescribed.  Do not use additional dosages or medications without Dr. Clark’s personal permission.
Also, DO NOT APPLY ICE, which is anti-inflammatory, at any time during the course of Prolotherapy.

What Post-therapeutic activity is advisable?

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In the case of Prolotherapy, normal activity movement, stretching, and exercise are important for the laying down of normal collagen in the healing of ligaments or tendons.  Therefore, just use common sense in your daily, exercise, or sports activity and do not join in any activity that is painful.

Move and exercise the treated joint as much as possible throughout the post-prolotherapeutic healing phase, including normal/routine daily activity movements.  However, limit the degree of range of motion and strength exercising to that which is tolerated BEFORE it becomes painful.  Let pain limit your movement or degree of stretching.  Do not participate in aggressive exercise training or sports activities until agreed upon by Dr. Clark.

DO NOT IMMOBILIZE any treated joint with a sling or restrictive bandage.  However, a sacroiliac belt may be appropriate following sacroiliac treatment if the sacroiliac joint is excessively hypermobile and painful.

Following low back and sacroiliac treatments, especially, avoid extreme turning movements, such as performed in Yoga (e.g., Warrior pose).

What post-therapeutic rehabilitative measures should be considered?

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Prolotherapy is a treatment for stabilizing joint instability due to ligament sprain injury or muscle tendon sprain injury.  Following joint stabilization, Dr. Clark recommends

  • William’s Flexion Exercises—for back pain patients during the course of Prolotherapy
  • Physical Therapy
  • Rolfing Therapy (Structural Integration)—and
  • Pilates Instruction

as rehabilitative therapies to help resolve residual compensatory ligamentous-muscular-myofascial restriction and core muscular weakness problems (e.g., core weakness, short leg aBduction weakness, scoliosis).

Gary B. Clark, MD, MPA | 1790 30th Street, Suite 230, Boulder, CO | (303) 444-5131